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Background Given the proposed dopaminergic mechanism of low-dose naltrexone (LDN), we examined its efficacy as augmentation for depressive breakthrough on pro-dopaminergic antidepressant regimens. Methods 12 adults (67% female, mean age = 45±12) with recurrent DSM-IV major depressive disorder (MDD) on dopaminergic antidepressant regimens (stimulants, dopamine agonists, bupropion [≥300 mg/day], aripiprazole [≤2.5 mg/day], or sertraline [≥150 mg/day]) were randomized to naltrexone 1 mg b.i.d. (n=6) or placebo (n=6) augmentation for 3 weeks. Results All subjects completed the trial. Hamilton Depression Rating Scale (HAM-D-17) scores (primary outcome measure) decreased from 21.2±2.0 to 11.7±7.7 for LDN, from 23.7±2.3 to 17.8±5.9 for placebo (Cohen's d=0.62; p=0.3 between treatment groups). HAM-D-28 scores decreased from 26.2±4.0 to 12.0±9.8 for LDN, from 26.3±2.6 to 19.8±6.6 for placebo (d=1.15; p=0.097). Montgomery-Asberg Depression Rating Scale (MADRS-10 item) scores decreased from 30.4±4.9 to 12.2±8.4 for LDN, from 30.7±4.3 to 22.8±8.5) for placebo (d=1.45; p=0.035). MADRS-15 item scores decreased from 36.6±6.2 to 13.2±8.8 for LDN, from 36.7±4.2 to 26.0±10.0 for placebo (d=1.49; p=0.035). Clinical Global Improvement Scale-Severity (CGI-S) scores decreased from 4.3±0.5 to 3.0±1.1 for LDN, from 4.3±0.5 to 4.0±0.6 for placebo (d=1.22; p=0.064). Limitations Small study; restrictions on allowed antidepressants. Conclusion LDN augmentation showed some benefit for MDD relapse on dopaminergic agents. Confirmation in larger studies is needed.

Previously, we found an anxiolytic effect of ziprasidone augmentation to escitalopram (compared with placebo augmentation) in patients with depression in an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial. Here, we carried out a post-hoc analysis, comparing changes in the Hamilton Depression and Anxiety Rating Scales between patients with anxious depression versus nonanxious depression, using a moderator analysis. Hamilton Depression Rating Scales total change scores from baseline and endpoint were not significantly different (interaction term P=0.91) in patients with anxious depression on ziprasidone augmentation (n=19; -9.1±4.9) or placebo (n=19; -6.1±8.9) versus patients without anxious depression on ziprasidone (n=52; -5.5±6.7) or placebo (n=49; -2.3±4.5). There was a trend toward statistical significance (interaction term P=0.1) in favor of patients without anxious depression for a difference in Hamilton Anxiety Rating Scale total change scores from baseline to endpoint [patients with anxious depression on ziprasidone augmentation (n=19; -2.7±5.3) or placebo (n=19; -3.3±5.8) versus patients without anxious depression on ziprasidone (n=51; -3.9±6.6) or placebo (n=44; -0.9±4.7)]. Ziprasidone augmentation was equally efficacious in treating depression in patients with versus without anxious depression. However, the observed anxiolytic effect for patients with higher anxiety was not clinically significant.

Background Despite the development of effective pharmacologic and cognitive behavioral treatments for obsessive-compulsive disorder (OCD), some patients continue to be treatment-refractory and severely impaired. Fiber tracts connecting orbitofrontal and dorsal anterior cingulate cortex with subcortical nuclei have been the target of neurosurgical lesions as well as deep brain stimulation in these patients. We report on the safety and efficacy of ventral gamma capsulotomy for patients with intractable OCD. Methods Fifty-five patients with severely disabling, treatment-refractory OCD received bilateral lesions in the ventral portion of the anterior limb of the internal capsule over a 20-year period using the Leksell Gamma Knife. The patients were prospectively followed over 3 years with psychiatric, neurologic, and neuropsychological assessments of safety and efficacy, as well as structural neuroimaging. Results Thirty-one of 55 patients (56%) had an improvement in the primary efficacy measure, the Yale-Brown Obsessive Compulsive Scale, of ≥35% over the 3-year follow-up period. Patients had significant improvements in depression, anxiety, quality of life, and global functioning. Patients tolerated the procedure well without significant acute adverse events. Five patients (9%) developed transient edema that required short courses of dexamethasone. Three patients (5%) developed cysts at long-term follow-up, 1 of whom developed radionecrosis resulting in an ongoing minimally conscious state. Conclusions Gamma Knife ventral capsulotomy is an effective radiosurgical procedure for many treatment-refractory OCD patients. A minority of patients developed cysts at long-term follow-up, 1 of whom had permanent neurological sequelae.

Background Several studies indicate that ketamine has rapid antidepressant effects in patients with treatment-resistant depression (TRD). The extent to which repeated doses of ketamine (versus placebo) reduce depression in the short and long term among outpatients with TRD and chronic, current suicidal ideation remains unknown. Methods Twenty-six medicated outpatients with severe major depressive disorder with current, chronic suicidal ideation were randomized in a double-blind fashion to six ketamine infusions (0.5 mg/kg over 45 minutes) or saline placebo over three weeks. Depression and suicidal ideation were assessed at baseline, 240 min post-infusion, and during a three-month follow-up phase. Results During the infusion phase, there was no differences in depression severity or suicidal ideation between placebo and ketamine (p = 0.47 and p = 0.32, respectively). At the end of the infusion phase, two patients in the ketamine group and one in the placebo group met criteria for remission of depression. At three-month follow-up, two patients in each group met criteria for remission from depression. Limitations Limitations include the small sample size, uncontrolled outpatient medication regimens, and restriction to outpatients, which may have resulted in lower levels of suicidal ideation than would be seen in emergency or inpatient settings. Conclusions Repeated, non-escalating doses of ketamine did not outperform placebo in this double-blind, placebo controlled study of patients with severe TRD and current, chronic suicidal ideation. This result may support our previously published open-label data that, in this severely and chronically ill outpatient population, the commonly used dose of 0.5 mg/kg is not sufficient.

We have previously shown an association between patient belief and treatment response in the Hypericum Depression Trial Study Group's 2002 study. We re-examined these data to determine whether clinical improvement was associated with physician belief about assigned therapy.Three hundred and forty adults with major depression and baseline scores ≥20 on the 17-item Hamilton Depression Scale (HDRS-17) were randomized to Hypericum 900-1500mg/day, sertraline 50-100mg/day, or placebo for 8 weeks. At week 8, physicians guessed their patients' treatment. We analyzed 277 subjects with at least one post-baseline visit and physician guess data. We examined association between guess and improvement in HDRS-17 and whether treatment assignment moderated the effect of belief on remission (final HDRS-17 score8).Patient and doctor guesses agreed at 53% for sertraline, 68% for Hypericum, and 52% for placebo (kappa=0.37). Doctors guessed placebo correctly (38%) more than sertraline (18%) or Hypericum (19%) (p=0.001). Adverse event scores were significantly greater among subjects for which the clinicians guessed Hypericum (p0.001) or sertraline (p=0.005) compared to placebo. Significant improvements in HDRS-17 score were found when comparing the Hypericum-guess (p0.001) or the sertraline-guess group (p0.001) against the placebo-guess group. Remission rates were significantly greater for subjects whose clinicians guessed sertraline (p0.001) or Hypericum (p0.001) versus placebo.Doctors tended to guess placebo more easily than Hypericum or sertraline, and their guesses tended to favor active therapies when improvement was more robust. Results show association but not causation, and merit more careful investigation.

Purpose National initiatives, such as the UK Improving Access to Psychological Therapies program (IAPT), demonstrate the feasibility of conducting empirical mental health assessments on a large scale, and similar initiatives exist in other countries. However, there is a lack of international consensus on which outcome domains are most salient to monitor treatment progress and how they should be measured. The aim of this project was to propose (1) an essential set of outcome domains relevant across countries and cultures, (2) a set of easily accessible patient-reported instruments, and (3) a psychometric approach to make scores from different instruments comparable. Methods Twenty-four experts, including ten health outcomes researchers, ten clinical experts from all continents, two patient advocates, and two ICHOM coordinators worked for seven months in a consensus building exercise to develop recommendations based on existing evidence using a structured consensus-driven modified Delphi technique. Results The group proposes to combine an assessment of potential outcome predictors at baseline (47 items: demographics, functional, clinical status, etc.), with repeated assessments of disease-specific symptoms during the treatment process (19 items: symptoms, side effects, etc.), and a comprehensive annual assessment of broader treatment outcomes (45 items: remission, absenteeism, etc.). Further, it is suggested reporting disease-specific symptoms for depression and anxiety on a standardized metric to increase comparability with other legacy instruments. All recommended instruments are provided online (www.ichom.org). Conclusion An international standard of health outcomes assessment has the potential to improve clinical decision making, enhance health care for the benefit of patients, and facilitate scientific knowledge. Electronic supplementary material The online version of this article (doi:10.1007/s11136-017-1659-5) contains supplementary material, which is available to authorized users.

In treated patients with major depressive disorder (MDD), residual symptoms are common and challenging to disentangle from possible antidepressant side effects. Our objective was to prospectively differentiate between rates of residual symptoms and treatment-emergent side effects.Participants in an episode of MDD were enrolled in a 6-week trial of an antidepressant. Assessments occurred at baseline and after 6 weeks of treatment, using the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ). Among treatment responders, residual symptoms were those that remained the same or improved. Side effects were defined as newly emergent or worsening symptoms.Of 403 participants, 284 completed (70.5%) the trial; 93 (32.7%) were treatment responders. Residual symptoms were common and represented a substantially greater burden than side effects at end point. This was true across symptoms of depression broadly, as captured by items with the QIDS-SR and the MGH CPFQ.Prospective assessment is crucial to discriminate between residual symptoms and side effects during antidepressant treatment. This study demonstrated that after 6 weeks of active treatment, symptoms are likely to persist despite response to treatment and are much less likely to represent side effects of medication treatment.

Background Failed treatment trials are common in major depressive disorder and treatment-resistant depression, and remotely performed multifaceted, centralized structured interviews can potentially enhance signal detection by ensuring that enrolled patients meet eligibility criteria. Methods We assessed the use of a specific remote structured interview that validated the diagnosis, level of treatment resistance, and depression severity. The objectives were to (1) assess the rate at which patients who were deemed eligible for participation in trials by site investigators were ineligible, (2) assess the reasons for ineligibility, (3) compare rates of ineligibility between academic and nonacademic sites, (4) compare eligibility between US and non-US sites, and (5) report the placebo response rates in trials utilizing this quality assurance approach, comparing its placebo response rates with those reported in the literature. Methods included a pooled analysis of 9 studies that utilized this methodology (SAFER interviews). Results Overall, 15.33% of patients who had been deemed eligible at research sites were not eligible after the structured interviews. The most common reason was that patients did not meet the study requirements for level of treatment resistance. Pass rates were significantly higher at non-US compared with US sites (94.6% vs 83.3%, respectively; P < 0.001). There was not a significant difference between academic and nonacademic sites (87.8% vs 82.4%; P = 0.08). Placebo response rates were 13.0% to 27.3%, below the 30% to 40% average in antidepressant clinical trials, suggesting a benefit of the quality assurance provided by these interviews. Conclusions The use of a remotely structured interview by experienced clinical researchers was feasible and possibly contributed to lower-than-average placebo response rates. The difference between US and non-US sites should be the subject of further research.

The aim of this study was to evaluate efficacy of ziprasidone monotherapy for major depressive disorder (MDD) with and without psychomotor symptoms. In accordance with the sequential parallel comparison design, 106 MDD patients (age 44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was carried out on 12-week double-blind treatment with either ziprasidone (40-160 mg/day) or placebo, divided into two phases of 6 weeks each to the assigned treatment sequences, drug/drug, placebo/placebo, and placebo/drug. Psychomotor symptoms were evaluated on the basis of the Mini-International Neuropsychiatric Interview at baseline. Efficacy assessments, on the basis of the 17-item Hamilton Depression Rating Scale (HDRS-17) and the Quick Inventory of Depressive Symptomatology Scale, Self-Rated (QIDS-SR), were performed every week throughout the trial. In phase I, ziprasidone monotherapy produced significant improvement in patients with psychomotor symptoms compared with placebo on the basis of HDRS-17 (F=5.95, P=0.017) and QIDS-SR (F=5.26, P=0.025) scores, whereas no significant changes were found in HDRS-17 (F=2.32, P=0.15) and QIDS-SR (F=3.70, P=0.074) scores in patients without psychomotor symptoms. In phase II, ziprasidone monotherapy produced no significant differences compared with placebo. In the pooled analysis, ziprasidone monotherapy showed significance according to QIDS-SR (Z=2.00, P=0.046) and a trend toward statistical significance according to the HDRS-17 (Z=1.66, P=0.10) in patients with psychomotor symptoms. Ziprasidone monotherapy may produce significant improvement compared with placebo in MDD patients with psychomotor symptoms.

Previous epidemiologic studies have revealed that East-Asian populations experience fewer depressive symptoms than American populations do. However, it is unclear whether this difference applies to clinical patients with major depressive disorder (MDD). This present study included 1592 Korean and 3744 American outpatients who were 18 years of age or older and met the Diagnostic and Statistical Manual of Mental Disorders, 4th ed. criteria for single or recurrent episodes of nonpsychotic MDD, and evaluated their symptoms of depression using the Hamilton Depression Rating Scale and the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form. Korean patients scored significantly lower for guilt and depressed mood items, and higher for hypochondriasis and suicidality items than American patients did, after adjusting for total Hamilton Depression Rating Scale scores. Conversely, no significant differences were found in quality and function of daily life between groups. Multivariate logistic regression analyses revealed that Korean patients experienced less frequent depressed mood and guilt, including verbal and nonverbal expression of depressed mood [adjusted odds ratio (AOR) = 0.14, 95% confidence interval (CI) 0.08-0.23] and feelings of punishment (AOR = 0.036, 95% CI 0.025-0.054) when compared with Americans after adjusting for age and sex. Conversely, Korean patients experienced more frequent suicidality and hypochondriasis, including suicidal ideas or gestures (AOR = 2.10, 95% CI 1.60-2.76) and self-absorption of hypochondriasis (AOR = 1.94, 95% CI 1.70-2.20). In conclusion, decreased expression of depressed mood and guilt may cause underdiagnosis of MDD in Korean patients. Early diagnosis of and intervention for depression and suicide may be delayed because of this specific cross-cultural difference in depression symptoms.

Given the increasing interest in demonstrating effectiveness in psychiatric treatment, the current paper seeks to advance outcome measurement in child psychiatry by demonstrating how more informative analytic strategies can be used to evaluate treatment in a real world setting using a brief, standardized parent-report measure. Questionnaires were obtained at intake for 1294 patients. Of these, 695 patients entered treatment and 531 (74%) had complete forms at intake and follow-up. Using this sample, we analyzed the data to determine effect sizes, rates of reliable improvement and deterioration, and rates of clinically significant improvement. Findings highlighted the utility of these approaches for evaluating treatment outcomes. Further suggestions for improving outcome measurement and evaluation are provided.

We sought to examine the efficacy and safety of acamprosate augmentation of escitalopram in patients with concurrent major depressive disorder (MDD) and alcohol use disorders. Twenty-three adults (43% female; mean ± SD age, 46 ± 14 years) were enrolled and received 12 weeks of treatment with psychosocial support; escitalopram, 10 to 30 mg/d; and either acamprosate, 2000 mg/d (n = 12), or identical placebo (n = 11). Outcomes included change in clinician ratings of depressive symptoms, MDD response and remission rates, changes in frequency and intensity of alcohol use, retention rates, and adverse events. Twelve subjects (acamprosate, n = 7; placebo, n = 5) completed the study. There was significant mean reduction in ratings of depressive symptoms from baseline in both treatment arms (P < 0.05), with no significant difference between the groups. Those in the acamprosate group had a 50% MDD response rate and a 42% remission rate, whereas those in the placebo arm had a 36% response and remission rate (not significant). Those assigned to acamprosate had significant reduction in number of drinks per week and drinks per month during the trial, whereas those assigned to placebo demonstrated no significant change in any alcohol use parameter, but the between-group difference was not significant. There were no significant associations between change in depressive symptoms and change in alcohol use. Attrition rates did not differ significantly between the 2 arms. Acamprosate added to escitalopram in adults with MDD and alcohol use disorders was associated with reduction in the frequency of alcohol use. The present study was not powered to detect superiority versus placebo. Further study in a larger sample is warranted.

Purpose Young adults with ADHD have been shown to be at increased risk for impairment in driving behaviors. Although stimulant medications have proven efficacy in reducing ADHD symptomatology, there is limited knowledge as to their effects on driving behavior. The focus of this report is on assessing the impact of lisdexamfetamine dimesylate (LDX) on driving behaviors in young adults with ADHD using a validated driving behavior questionnaire. Methods This assessment was carried out in the context of a randomized, double-blind, 6-week, placebo-controlled, parallel-design study of LDX versus placebo. Subjects were 61 outpatients of both sexes, 18–26 years of age, who met Diagnostic and Statistical Manual of Mental Disorders, fourth edition, criteria for ADHD. Subjects were randomized to receive LDX or placebo for 6 weeks. Driving behavior was assessed at baseline and at the end of treatment using a U.S. version of the Manchester Driving Behavior Questionnaire (DBQ). Results Highly significant improvements were documented on LDX, over placebo, in driving behaviors assessed through the DBQ in measures of driving errors, driving lapses, and a trend toward fewer driving violations. There were no meaningful associations between these DBQ results and previously documented changes in a laboratory driving simulation paradigm or with improvement in symptoms of ADHD assessed through the ADHD rating scale. Conclusions LDX treatment was associated with significant improvements in self-reported driving behaviors that were independent of improvement in symptoms of ADHD. These results suggest that LDX may reduce behaviors associated with driving risks in young adults with ADHD.

Objective This pilot, randomized clinical trial investigates the effectiveness of tai chi as the primary treatment for Chinese Americans with major depressive disorder (MDD). Methods 67 Chinese Americans with DSM-IV MDD and no treatment for depression were recruited between March 2012 and April 2013 and randomized (1:1:1) into a tai chi intervention, an education program, or a waitlisted group for 12 weeks. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS₁₇); positive response for this outcome was defined as a decrease in total score of 50% or more, and remission was defined as HDRS₁₇ ≤ 7. Results Participants (N = 67) were 72% female with a mean age of 54 ± 13 years. No serious adverse events were reported. After the end of the 12-week intervention, response rates were 25%, 21%, and 56%, and remission rates were 10%, 21%, and 50% for the waitlisted, education, and tai chi intervention groups, respectively. The tai chi group showed improved treatment response when compared to both the waitlisted group (odds ratio [OR] = 2.11; 95% CI, 1.01-4.46) and to the education group (OR = 8.90; 95% CI, 1.17-67.70). Tai chi intervention showed significantly improved remission rate over the waitlisted group (OR = 3.01; 95% CI, 1.25-7.10), and a trend of improved remission compared to the education group (OR = 4.40; 95% CI, 0.78-24.17). Conclusions As the primary treatment, tai chi improved treatment outcomes for Chinese Americans with MDD over both passive and active control groups. Trial registration ClinicalTrials.gov identifier: NCT01619631.

A 2-phase, mixed methods study was conducted to develop a Parenting Concerns Questionnaire (PCQ) for adults with cancer. Limited information about this area of psychosocial distress highlights the need for a measurement tool that can identify adult oncology patients with heightened parenting concerns who could benefit from additional intervention.Telephone focus groups were conducted with 16 oncology patients who had children 18 years old and younger. Group interview transcripts were analyzed to generate qualitative themes and candidate items for the PCQ. A 38-item version of the questionnaire was completed by 173 oncology outpatients who had children 18 years old and under. Participants also completed the Distress Thermometer, HADS (Hospital Anxiety and Depression Scale), and FACT-G (Functional Assessment of Cancer Therapy-General). Exploratory factor analyses revealed the emergence of 3 subscales of 5 items each, yielding a 15-item questionnaire. Associations between total PCQ scores, standardized measures of distress, depression, anxiety, quality of life, and demographic and illness characteristics were examined.The 15-item PCQ demonstrates good internal consistency (Cronbach's α = .83). PCQ scores were significantly associated (P.01) with standardized measures of psychosocial distress (Distress Thermometer, HADS, and FACT-G) in the expected directions. Higher PCQ scores were associated with female sex, single parenthood, metastatic or recurrent cancer, subjective understanding of incurable disease, comorbid chronic health condition, and current mental health treatment.The PCQ proved a reliable and valid measure of parenting distress among cancer patients, and thus merits further study.

Objectives: Scrupulosity is a relatively common but understudied subtype of obsessive-compulsive disorder (OCD) characterized by religious or moral fears. It is difficult to treat and frequently disabling. We examined scrupulosity as it relates to (a) treatment-seeking behavior and perceived treatment gains, (b) the perceived effect of symptoms on religious experience, and (c) conceptions of God. Method: Seventy-two individuals with scrupulous OCD (mean age = 36; 70% women) and 75 individuals with nonscrupulous OCD (mean age = 38; 81% women) completed an internet-based survey. Results: The groups did not differ on demographic variables or overall OCD severity. Compared with the nonscrupulous group, the scrupulous group was (a) more religious, (b) more likely to seek pastoral counseling, (c) less likely to seek medication treatment, and (d) more likely to report that symptoms interfered with their religious experience. Indeed, most scrupulous individuals endorsed that their symptoms interfered with their religious experience. Scrupulous individuals with a more negative concept of God experienced more severe symptoms, whereas a positive description of God was unrelated to severity of scrupulosity in this group. Nearly one in five scrupulous participants reported no religious affiliation. Conclusions: Scrupulous individuals have unique treatment-seeking preferences. Moreover, most scrupulous individuals perceive their symptoms as interfering with their religious experience. Focusing on the religious costs and benefits of scrupulous rituals might have clinical utility. Finally, scrupulous individuals with a more negative concept of God experienced more severe symptoms. Future research is necessary to evaluate whether addressing such concepts can improve treatment outcome. © 2011 Wiley Periodicals, Inc. J Clin Psychol 67:1–9, 2011.

OBJECTIVE To reanalyze data from a 2002 study by the Hypericum Depression Trial Study Group to determine whether patients who believed they were receiving active therapy rather than placebo obtained greater improvement, independent of treatment. METHOD Three hundred forty adults with major depressive disorder (according to the Structured Clinical Interview for DSM-IV) and baseline scores of ≥ 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17) were randomized to Hypericum perforatum 900-1,500 mg/d, sertraline 50-100 mg/d, or placebo and were asked to guess their assigned treatment after 8 weeks. This reanalysis of data was performed from October 1, 2009, to April 15, 2011. The intent-to-treat sample included 207 subjects (mean age = 44 years) who had (1) at least 1 postbaseline visit; (2) adherence data based on serum levels of hyperforin, sertraline, and desmethylsertraline; and (3) guess data. Univariate factorial analysis of variance was used to determine whether treatment assignment affected clinical improvement according to HDRS-17 score and whether this effect was moderated by patient guess of sertraline, Hypericum, or placebo. Analysis of covariance was used to determine whether side effects mediated improvement in the context of patient guess and assigned treatment. χ₂ analyses compared response rates (≥ 50% decrease in HDRS-17 score) between the guess groups and between the treatment groups within each guess group. RESULTS Assigned treatment had no significant effect on clinical improvement (P = .65), but patient guess was significantly associated with improvement (P < .001), and treatment and guess interacted significantly (P = .005). Among subjects who guessed placebo, clinical improvement was small and did not differ significantly across treatments. Among subjects who guessed Hypericum, improvement was large and did not differ significantly across treatments. Among subjects who guessed sertraline, those who received placebo or sertraline had large improvements, but those who received Hypericum had significantly less improvement (P < .001). Similar findings were obtained for response rates. CONCLUSIONS Patient beliefs regarding treatment may have a stronger association with clinical outcome than the actual medication received, and the strength of this association may depend upon the particular combination of treatment guessed and treatment received.

Medical specialties, including surgery, obstetrics, anesthesia, critical care, and trauma, have adopted simulation technology for measuring clinical competency as a routine part of their residency training programs; yet, simulation technologies have rarely been adapted or used for psychiatry training. The authors describe the development of a web-based computer simulation tool intended to assess physician competence in obtaining informed consent before prescribing antipsychotic medication to a simulated patient with symptoms of psychosis. Eighteen residents participated in a pilot study of the Computer Simulation Assessment Tool (CSAT). Outcome measures included physician performance on required elements, pre- and post-test measures of physician confidence in obtaining informed consent, and levels of system usability. Data suggested that the CSAT increased physician confidence in obtaining informed consent and that it was easy to use. The CSAT was an effective educational tool in simulating patient—physician interactions, and it may serve as a model for use of other web-based simulations to augment traditional teaching methods in residency education.

OBJECTIVE This study sought to investigate the likelihood that subjects will respond to continued antidepressant therapy when little or no benefit has yet been observed. METHOD Six hundred twenty-seven subjects diagnosed with DSM-IV major depressive disorder were recruited in a 12-week open-label trial with fluoxetine, which was designed as a preliminary phase to a subsequent 52-week continuation trial, which was conducted in 1997-2003. For each week of the study, a calculation was made for all subjects who had heretofore demonstrated little or no improvement as to the likelihood of converting to a positive response in subsequent weeks as measured by the Clinical Global Impressions scale, the primary outcome measure. In order to compare our findings with prior research, we focused primarily on outcomes at weeks 6, 8, and 12. RESULTS The likelihood of converting to a positive response decreased the longer subjects remained unimproved. When week 6 was used as the end point, the likelihood of converting to a positive response for unimproved subjects at week 1 was 36% (n = 302); the respective conversion rates for weeks 2-5 were 29% (n = 208) at week 2, 18% (n = 151) at week 3, 17% (n = 120) at week 4, and 9% (n = 91) at week 5. When week 8 was used as the end point, the likelihood of converting to a positive response for unimproved subjects at week 4 was 23% (n = 118) and, at week 6, was 10% (n = 61). Finally, when week 12 was used as the end point, the likelihood of unimproved subjects at weeks 4, 6, and 8 converting to a positive response at week 12 was 50% (n = 117), 33% (n = 60), and 30% (n = 46), respectively. CONCLUSIONS The study adds to a small, but growing literature that gives clinicians some guidelines to help decide whether to continue an antidepressant trial when little or no benefit has yet been observed. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00427128.

Previous findings suggested a unique role that depression symptoms might play in the comorbid relationship between obsessive-compulsive disorder (OCD) and posttraumatic stress disorder (PTSD). However, the nature of this role remains unclear. Thus, the current study examined ways in which OCD and PTSD symptoms vary as a function of depression, as well as the mediating role of depression in the OCD-PTSD relationship, in 104 individuals seeking treatment for refractory OCD. Findings revealed that depressed individuals in the treatment-refractory OCD sample report higher levels of overall obsessing and greater severity of PTSD. In addition, depression appeared to mediate the relation between OCD and PTSD. Implications of findings are discussed.

Objective We test the hypothesis that racial or ethnic differences exist in relapse rates to fluoxetine discontinuation in major depressive disorder (MDD). Method Data are from a prospective study examining the relapse rates secondary to fluoxetine discontinuation in MDD. Subjects in the discontinuation phase consisted of 255 adults aged 18 to 65: 214 subjects who self-identified as white, 22 as African American, 13 as Latino American, and 6 as Asian American. Results In both the fluoxetine and placebo groups, no statistically significant differences emerged when comparing time to relapse for minority groups as compared to the white population. Adjusting for statistically significant predictors of relapse (symptom severity, neurovegetative symptom pattern, sex) and for educational level did not change the outcome of the survival analyses. Conclusions Although the size of minority groups in this sample was modest, in a randomized, controlled trial setting, minority and white patients may have similar rates of relapse in MDD. This finding reinforces the importance of maintenance treatment in relapse for both minority as well as white patients with MDD. Given the self-selecting nature of clinical trials, future studies are needed to further examine the potential influence of underlying cultural factors on clinical outcomes in minority populations.

Objective/Introduction: We sought to characterize the impact of the 90-item Symptom Checklist (SCL-90) subscales for paranoid ideation (PI) and psychoticism (P) in patients with major depressive disorder (MDD), on acute anti-depressant response and on relapse prevention.Methods: Subjects with Structured Clinical Interview for DSM Disorders-diagnosed non-psychotic MDD were recruited into a clinical trial of open-label fluoxetine 10–60 mg/day for 12 weeks, followed by double-blind randomization of responders (n=262) to fluoxetine continuation or placebo for 12 months. PI and P were assessed with the patient-rated SCL-90. The association of these symptoms with response to treatment was assessed by logistic regression.Results: We found significant decreases in PI and P during acute treatment phase for fluoxetine responders and nonresponders, although only 10.3% and 7.5% of patients experienced a ≥50% reduction in PI and P scores, respectively. Neither PI nor P scores significantly predicted time to relapse. P scores predicted a lower response rate to treatment with fluoxetine.Discussion: The results of the present study suggest that there is a significant relationship between the presence of psychoticism in patients with nonpsychotic MDD, and the likelihood of overall depressive symptom improvement following a trial of monotherapy with fluoxetine.Conclusion: An increased burden of psychoticism in depressed subjects may confer poorer response to fluoxetine, but not increased risk of relapse among fluoxetine responders.

The objective of this study was to assess the relationship between early changes in anxiety/somatization symptoms and treatment outcome among major depressive disorder patients during a 12-week trial of fluoxetine. We also examined the relationship between anxious depression and treatment response. Five hundred and ten major depressive disorder patients received 12 weeks of fluoxetine with flexible dosing [target dosages: 10 mg/day (week 1), 20 mg/day (weeks 2-4), 40 mg/day (weeks 4-8), and 60 mg/day (weeks 5-12)]. We assessed the relationship between early changes in 17-item Hamilton Rating Scale for Depression (HAMD-17)-anxiety/somatization factor items and depressive remission, as well as whether anxious depression at baseline predicted remission at study endpoint. Baseline HAMD-17 scores were considered as covariates and the Bonferroni correction (P < or = 0.008) was used for multiple comparisons. Adjusting for baseline HAMD-17 scores, patients who experienced greater early improvement in somatic symptoms (gastrointestinal) were significantly more likely to attain remission (HAMD-17

Relapse of major depressive disorder (MDD) is a common clinical problem. Identifying relapse predictors could lead to strategies that reduce relapse risk. This study is designed to determine whether residual symptoms predict relapse risk during the continuation/maintenance treatment of MDD. 570 MDD patients received open-label fluoxetine for 12 weeks. Under double blind conditions, 262 patients who responded by week 12 were randomly assigned to continue fluoxetine or switch to placebo for 52 weeks or until relapse. Residual symptoms were measured using the Symptom Checklist-90 and the Symptom Questionnaire. The relationship between residual symptom severity and relapse risk was assessed. Without adjusting for overall residual symptom severity, a greater severity of residual obsessive-compulsive and phobic anxiety symptoms predicted greater relapse risk. After adjusting for overall residual symptom severity, only severity of phobic anxiety symptoms predicted relapse risk. The predictive value of phobic anxiety symptoms with respect to relapse risk was independent of treatment assignment. The results indicated that there may be a specific pattern of residual symptoms associated with depressive relapse during antidepressant continuation/maintenance, which is unrelated to treatment assignment. Future studies are needed to further explore the relationship between residual symptoms and relapse risk in MDD. Clinical implications: (1) It is important to treat residual symptoms among antidepressant responders/remitters in order to decrease relapse risk. (2) Clinicians should target residual phobic anxiety symptoms in order to decrease relapse risk. (3) Clinicians should target residual obsessive-compulsive symptoms in order to decrease relapse risk. Limitations: (1) limited generalizability due to inclusion/exclusion criteria; (2) lack of active comparator treatment group; (3) post hoc analysis.

Although personality disorder (PD) comorbidity has been associated with poor treatment outcome in major depressive disorder (MDD), little is known about mechanisms mediating this link. Converging evidence suggests that maladaptive cognitive patterns, particularly in interaction with stressors, might lead to poor treatment outcome in MDD subjects with PD pathology. The goal of this study was to test the role of PD comorbidity, cognitive vulnerability, and perceived stress in treatment outcome in MDD. Three hundred eighty-four MDD outpatients were enrolled in an 8-week open-label treatment of fluoxetine. Structural equation modeling and path analyses revealed that the effect of PD vulnerability on treatment outcome was fully mediated by increased pretreatment cognitive vulnerability and depression severity, which led to increased stress perception after treatment and poorer antidepressant response. Depressogenic cognitions might be continuously activated by chronic distress in MDD subjects reporting axis II pathology, leading to stress exacerbation and eventually poorer treatment outcome.

Objective To examine motoric, cardiovascular, endocrine, and metabolic effects of adjunctive ziprasidone in adults with major depressive disorder (MDD) and prior nonresponse to 8 weeks of open-label escitalopram. Methods A multicenter, parallel, randomized, double-blind, placebo-controlled trial was conducted at 3 US academic medical centers from July 2008 to October 2013. Recruited were 139 outpatients with persistent DSM-IV MDD following an 8-week open-label trial of escitalopram. Subjects were then randomized to adjunctive ziprasidone (escitalopram + ziprasidone, n = 71) or placebo (escitalopram + placebo, n = 68) for 8 additional weeks. Cardiac and metabolic measures were obtained at each treatment visit. Barnes Akathisia Scale and Abnormal Involuntary Movement Scale (AIMS) scores were also obtained. Changes in outcome measures for each treatment group were compared by independent-samples t test. Results A trend toward significance (P = .06) in corrected QT interval (QTc) increase was observed for ziprasidone (mean [SD] = 8.8 [20.2] milliseconds) versus placebo (-0.02 [25.5] milliseconds). Ziprasidone-treated patients had a significantly greater increase in global akathisia scores (P = .01) and significant weight increase (mean [SD] = 3.5 [11.8] kg, or 7.7 [26.1] lb) compared to placebo (1.0 [6.4] kg, or 2.2 [14.1] lb) (P = .03). No significant changes in AIMS scores were observed for either treatment group. Conclusions Adjunctive ziprasidone, added to escitalopram, led to a greater weight gain and greater but modest akathisia compared to placebo. The effect of ziprasidone on QTc showed a trend toward significance, and therefore caution should be used in the administration of ziprasidone. While ziprasidone augmentation in patients with MDD appears safe, precautions should be taken in practice, specifically regular monitoring of electrocardiogram, weight, extrapyramidal symptoms, and involuntary movements. Trial registration ClinicalTrials.gov identifier: NCT00633399​​.

Purpose The purpose of this study was to assess the association of obsessive-compulsive symptoms (OCS) with suicide risk among college students. Methods Subjects were 474 college students who attended mental health screenings at two private universities and completed multiple self-report questionnaires. Results Presence of one or more OCS was associated with an increased odds ratio of suicide risk of approximately 2.4, although this was no longer a significant risk factor when controlling for depressive symptoms. Of the OCS assessed, only obsessions about speaking or acting violently remained an independent risk factor for suicidality over and above depression. Conclusions Although our study was cross-sectional in nature and thus cannot determine causality, increased burden of particular OCS symptom clusters, such as violent or aggressive obsessions, may increase risk among college students, for suicidal ideation.

The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures.Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group.Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.

Psychosocial treatments and medications both have been shown to be effective in treating major depressive disorder. We hypothesized that cognitive-behavioral therapy (CBT) would outperform medication on measures of cognitive change.We randomized depressed individuals to 12 weeks of CBT (n = 15) or escitalopram (n = 11). In an intent-to-treat analysis (n = 26), we conducted a repeated measures analysis of variance to examine changes in depressive symptoms (ie, 17-item Hamilton Depression Rating Scale, Beck Depression Inventory), anhedonia (ie, Snaith-Hamilton Pleasure Scale), cognitive measures (ie, Dysfunctional Attitudes Scale, Automatic Thoughts Questionnaire, Perceived Stress Scale), and quality of life (ie, Quality of Life Enjoyment and Satisfaction Questionnaire) at 4 time points: baseline, week 4, week 8, and week 12. Treatment for both groups started at baseline, and patients received either 12 weeks of individual CBT or 12 weeks of escitalopram with flexible dosing (10 to 20 mg).Collapsing the escitalopram and CBT groups, there were statistically significant pre-post changes on all outcome measures. However, there were no statistically significant differences between treatment groups on any of the outcome measures, including cognitive measures across time points.Our results suggest that both CBT and escitalopram have similar effects across a variety of domains and that, in contrast to our a priori hypothesis, CBT and escitalopram were associated with comparable changes on cognitive measures.

We examined whether fatigue was associated with greater symptomatic burden and functional impairment in college students with depressive symptoms.Using data from the self-report Beck Depression Inventory (BDI), we stratified a group of 287 students endorsing significant symptoms of depression (BDI score ≥ 13) into 3 levels: no fatigue, mild fatigue, or moderate/severe fatigue. We then compared the 3 levels of fatigue across a battery of psychiatric and functional outcome measures.Approximately 87% of students endorsed at least mild fatigue. Students with moderate/severe fatigue had significantly greater depressive symptom severity compared with those with mild or no fatigue and scored higher on a suicide risk measure than those with mild fatigue. Students with severe fatigue evidenced greater frequency and intensity of anxiety than those with mild or no fatigue. Reported cognitive and functional impairment increased significantly as fatigue worsened.Depressed college students with symptoms of fatigue demonstrated functional impairment and symptomatic burden that worsened with increasing levels of fatigue. Assessing and treating symptoms of fatigue appears warranted within this population.

Objective To compare asthma care roles of maternal and paternal caregivers, and examine associations between caregiver involvement and the outcomes of adherence, morbidity, and parental quality of life (QoL). Methods Mothers and fathers in 63 families of children, ages 5-9 years, with persistent asthma completed semistructured interviews and questionnaires. Adherence was measured via electronic monitoring. Paired t tests compared parental asthma care roles, and analysis of covariance, controlling for socioeconomic status, evaluated associations of asthma outcomes with caregiver involvement scores. Results Mothers had higher scores on measures of involvement, beliefs in medication necessity, and on four subscales of the Family Asthma Management System Scale interview (Asthma Knowledge, Relationship with Provider, Symptom Assessment, and Response to Symptoms). Maternal QoL was lowest when both maternal and paternal involvement was high. Paternal involvement was associated with increased morbidity. Conclusions There is room for enhancement of fathers' asthma care roles. Higher levels of paternal involvement may be driven by family need.

Objective Skills for Life (SFL) is the largest school-based mental health program in the world, screening and providing services to more than 1,000,000 students in Chile over the past decade. This is the first external evaluation of the program. Method Of the 8,372 primary schools in Chile in 2010 that received public funding, one-fifth (1,637) elected to participate in SFL. Each year, all first- and third-grade students in these schools are screened with validated teacher- and parent-completed measures of psychosocial functioning (the Teacher Observation of Classroom Adaptation–Re-Revised [TOCA-RR] and the Pediatric Symptom Checklist–Chile [PSC-CL]). Students identified as being at risk on the TOCA-RR in first grade are referred to a standardized 10-session preventive intervention in second grade. This article explores the relationships between workshop participation and changes in TOCA-RR and PSC-CL scores, attendance, and promotion from third to fourth grades. Results In all, 16.4% of students were identified as being at-risk on the TOCA-RR. Statistically significant relationships were found between the number of workshop sessions attended and improvements in behavioral and academic outcomes after controlling for nonrandom selection into exposure and loss to follow-up. Effect sizes for the difference between attending most (7–10) versus fewer (0–6) sessions ranged from 0.08 to 0.16 standard deviations. Conclusion This study provides empirical evidence that a large-scale mental health intervention early in schooling is significantly associated with improved behavioral and academic outcomes. Future research is needed to implement more rigorous experimental evaluation of the program, to examine longer-term effects, and to investigate possible predictors of heterogeneity of treatment response.

The Pediatric Symptom Checklist (PSC) is a widely-used, parent-completed measure of children’s emotional and behavioral functioning. Previous research has shown that the PSC and its subscales are generally responsive to patient progress over the course of psychiatric treatment. In this naturalistic study, we examined the performance and utility of the five-item PSC Internalizing Subscale (PSC-IS) as an assessment of routine treatment in outpatient pediatric psychiatry. Parents and clinicians of 1,593 patients aged 17 or younger completed standardized measures at intake and three-month follow-up appointments. Comparisons between PSC-IS scores and clinician-reported diagnoses, internalizing symptoms, and overall functioning showed acceptable levels of agreement. Change scores on the PSC-IS were also larger among patients with internalizing diagnoses than those with non-internalizing diagnoses. As a brief measure of internalizing symptoms, the PSC may be particularly useful to mental health clinicians treating youth with depression and anxiety as a quality assurance or treatment outcome measure.

Theoretical, clinical, and empirical implications of the functional connections between symptoms of obsessive-compulsive disorder (OCD) and posttraumatic stress disorder (PTSD) are abundant. As such, four cases are presented here of men and women who met criteria for comorbid OCD and PTSD. All had been diagnosed with treatment-resistant OCD and were seeking treatment from an OCD specialty clinic or institute, all reported a history of traumatic experiences prior to the onset of OCD, and all appeared to demonstrate negative treatment outcomes. Upon examination, it appeared that symptoms of OCD and PTSD were connected such that decreases in OCD-specific symptoms related to increases in PTSD-specific symptoms, and increases in OCD-specific symptoms related to decreases in PTSD-specific symptoms. Speculations about the function of OCD symptoms in relation to post-traumatic psychopathology are put forth; and theoretical, research, and treatment implications are discussed.

Long-term outcome associated with cingulotomy for obsessive-compulsive disorder (OCD) was prospectively assessed. Findings are reported for 18 patients previously described in 1995 and for 26 new patients.An open preoperative and follow-up assessment was conducted at multiple time points for 44 patients undergoing one or more cingulotomies for treatment-refractory OCD. The patients were assessed by using the Structured Clinical Interview for DSM-III-R preoperatively and with the Yale-Brown Obsessive Compulsive Scale, the Beck Depression Inventory, and the Sickness Impact Profile both preoperatively and at all follow-up assessments. The patients completed clinical global improvement scales at all follow-up assessments.At mean follow-up of 32 months after one or more cingulotomies, 14 patients (32%) met criteria for treatment response and six others (14%) were partial responders. Thus, 20 patients (45%) were at least partial responders at long-term follow-up after one or more cingulotomies. Few adverse effects were reported.Thirty-two percent to 45% of patients previously unresponsive to medication and behavioral treatments for OCD were at least partly improved after cingulotomy. Cingulotomy remains a viable treatment option for patients with severe treatment-refractory OCD.

In medicine, it is critical that clinicians demonstrate both empathy (perceived as warmth) and competence. Perceptions of these qualities are often intuitive and are based on nonverbal behavior. Emphasizing both warmth and competence may prove problematic, however, because there is evidence that they are inversely related in other settings. We hypothesize that perceptions of physician competence will instead be positively correlated with perceptions of physician warmth and empathy, potentially due to changing conceptions of the physician’s role. We test this hypothesis in an analog medical context using a large online sample, manipulating physician nonverbal behaviors suggested to communicate empathy (e.g. eye contact) and competence (the physician’s white coat). Participants rated physicians displaying empathic nonverbal behavior as more empathic, warm, and more competent than physicians displaying unempathic nonverbal behavior, adjusting for mood. We found no warmth/competence tradeoff and, additionally, no significant effects of the white coat. Further, compared with male participants, female participants perceived physicians displaying unempathic nonverbal behavior as less empathic. Given the significant consequences of clinician empathy, it is important for clinicians to learn how nonverbal behavior contributes to perceptions of warmth, and use it as another tool to improve their patients’ emotional and physical health.

OBJECTIVE Obsessive-compulsive symptoms (OCS) may be underrecognized in patients suffering from major depressive disorder. These patients may not receive optimal psychopharmacologic or psychological treatment if their OCS are not attended to. We performed a secondary analysis of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial database, the largest effectiveness study of "real-world" depression ever conducted, to determine the frequency of OCS and their effects on depression outcome. METHOD 3,984 adult subjects without a previous selective serotonin reuptake inhibitor trial for their current major depressive episode, per DSM-IV diagnostic criteria, had data for rating scales of interest at entry into Level 1 of the STAR*D trial, a 12-week open trial of citalopram at a dose of 20-60 mg/d to assess rates of depression remission. Our primary interest was the OCD subscale of the Psychiatric Diagnostic Screening Questionnaire. RESULTS At study entry, 53% of the STAR*D sample (which excluded patients with primary obsessive-compulsive disorder) endorsed ≥ 1 OCS, and 14% endorsed ≥ 4 OCS. Subjects endorsing ≥ 4 OCS had significantly lower corrected odds of depression remission on both the 17-item Hamilton Depression Rating Scale (HDRS-17) (OR = 0.61) and the Quick Inventory of Depressive Symptomatology (odds ratio [OR] = 0.51). Number of OCS endorsed was positively correlated with HDRS-17 score (r = 0.26, P < .0001). Consistent with findings from the Dunedin, New Zealand Community Study, the most common obsessions were doubts of having inadvertently caused harm and violent obsessions. CONCLUSIONS OCS are common in depressed outpatients and are often not attended to. They impact clinical recovery from depression and should be screened for since sufferers are often reluctant to disclose these symptoms. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT00021528.

The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) was developed to assess clinically relevant cognitive and physical symptoms associated with depression that are not adequately assessed by traditional measures. Although the CPFQ has been shown previously to be a reliable and valid measure, the purpose of the present study was to provide additional evidence using larger samples from 4 independent clinical trials that were designed to test the efficacy and safety of different antidepressants.The psychometric analyses were based on data from 4 independent clinical trials that were designed to test the safety and efficacy of different antidepressants. Reliability of the items and of the overall questionnaire was evaluated with principal components analysis, whereas validity was assessed by associations of the questionnaire scores with convergent and divergent external criteria.Overall, the results have replicated previous findings that the CPFQ has good internal reliability. Validation also is strengthened by the demonstration of predictive differences among known groups as well as a sensitivity to change with antidepressant treatment.Results support the use of the CPFQ as a valuable instrument for the detection of clinically relevant symptoms that are not captured by typical measures of depression used for the assessment of treatment outcomes.

Anxious depression, defined as major depressive disorder (MDD) accompanied by high levels of anxiety, seems to be difficult to treat with traditional antidepressant monotherapy. The purpose of this study was to assess the efficacy of ziprasidone monotherapy in patients with anxious depression versus non-anxious depression. One hundred and twenty outpatients were enrolled in a 12-week study that was divided into two 6-week periods according to the sequential parallel comparison design. Patients were randomized in a 2:3:3 multi-ratio to receive ziprasidone for 12 weeks, placebo for 6 weeks, followed by ziprasidone for 6 weeks, or placebo for 12 weeks. Efficacy was measured according to the 17-item Hamilton Depression Rating Scale (HRDS-17), Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-SR). Anxious depression was defined as a score of ≥7 on the HDRS-17 anxiety/somatization subscale. In phase I and II, ziprasidone monotherapy led to no significant changes compared with placebo on the HDRS-17 and QIDS-SR scores in patients with both anxious and non-anxious depression. In the pooled analysis, ziprasidone monotherapy also produced no significance on the HDRS-17 (Z = 0.25, P = 0.80) and QIDS-SR (Z = 0.43, P = 0.67) in patients with anxious depression. In conclusion, treatment with ziprasidone monotherapy may produce no significant improvement compared with placebo in patients with in anxious depression. Trial registration ClinicalTrials.gov identifier: NCT00555997 .

Significant racial and ethnic differences exist in the receipt of psychiatric care and help-seeking. We examined the relationship between race/ethnicity and psychological well-being and functioning in psychiatric outpatients. We analyzed intake data for 8,697 adult patients in psychiatry clinics in New England between 2008 and 2010. Patients rated psychological wellbeing using the Schwartz Outcome Scale (SOS-10); clinicians rated the Global Assessment of Functioning (GAF). In an analysis of variance with covariates, race/ethnicity exhibited a small but statistically significant association with GAF (F(4,8481)=17.902, plt;.001) and SOS-10 scores (F(4,8165)=7.271, plt;.001). However, after adjustment for physical health and socioeconomic variables, these differences became insignificant or were reversed. Our findings suggest that the relationship between race/ethnicity and mental health may be confounded by other socioeconomic or health differences and may be small compared with the effect of those variables. Future studies on race and psychological well-being should take social determinants of health into consideration.

The world's largest school-based mental health program, Habilidades para la Vida (Skills for Life (SFL)), has been operating on a national scale in Chile for 15 years. SFL's activities include using standardized measures to screen elementary school students and pro- viding preventive workshops to students at risk for mental health problems. This paper used SFL's data on 37,397 students who were in first grade in 2009 and third grade in 2011 to ascertain whether first grade mental health pre- dicted subsequent academic achievement and whether remission of mental health problems predicted improved academic outcomes. Results showed that mental health was a significant predictor of future academic performance and that, overall, students whose mental health improved between first and third grade made better academic pro- gress than students whose mental health did not improve or worsened. Our findings suggest that school-based mental health programs like SFL may help improve students' academic outcomes.

The use of psychotropic medications for children and adolescents with attention and depression problems continues to generate both attention in the news media and controversy within the field. Given that the United Kingdom has recently issued guidelines for its national health service that differ substantially from those in the United States, the time is ripe to reexamine the evidence. The purpose of this article is to describe the UK's new "stepped care" guidelines for treating attention and depression problems in children and to compare them to the US guidelines issued by the American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry. Our findings are that, despite many similarities, the UK guidelines are generally more conservative in their recommendations for medication use, especially for children experiencing only moderate impairment. Our article also compares prescription and diagnosis rates in the UK and the US, and reports evidence for lower rates of prescribing in the UK, despite some evidence that the rates of problems may not differ substantially. We conclude by noting that the existence of an alternative standard provides validation for clinicians or families who prefer to take a more conservative approach to medication use. The two different approaches to care also provide a valuable opportunity for research to determine whether the approaches result in different treatment outcomes.

Introduction: Despite published recommended best practices for full disclosure and apology to patients and families after adverse medical events, actual practice can be inadequate. The use of ‘‘cognitive aids’’ to help practitioners manage complex critical events has been successful in a variety of fields and healthcare. We wished to extend this concept to disclosure and apology events. The aim of this study was to test if a brief opportunity to review a best practice guideline for disclosure and apology would improve communication performance. Methods: Thirty pairs of experienced obstetricians and labor nurses participated in a 3-part exercise with mixed-realism simulation. The first part used a standardized actor patient to meet the obstetrical team. The second part used a high-fidelity simulation leading to an adverse medical event (retained sponge), and the third part used standardized actors, patient, and husband, who systematically move through stages of grief response. The participants were randomized into 2 groups, one was provided with a cognitive aid in the form of a best practice guideline for disclosure and apology and the other was only given time to plan. Four blinded raters working in pairs scored subjects on a 7-point scale using a previously developed assessment instrument modified for this study. Results: Pooled ratings of the disclosure and apology discussion for the intervention group (n = 167, mean = 4.9, SD = 0.92) were higher than those from the control group (n = 167, mean = 4.3, SD = 1.21) (P G0.0001). One specific element was rated higher for the intervention group than the control group; posture toward the patient (n = 27, mean = 5.1, SD = 0.82 versus n = 28, mean = 4.3, SD = 1.33) (P = 0.020). The elements of dealing with anger, dealing with depression, dealing with denial, bargaining, and acceptance were not different. Conclusions: Experienced practitioners performed better in a simulated disclosure and apology conversation after reviewing a cognitive aid in the form of a best practice guideline than a control group that was only given time to prepare.

The effectiveness of “home-based” exposure and response prevention was assessed in a series of 11 subjects with obsessive–compulsive disorder (OCD). Patients received 24 treatment sessions in a range of natural settings and situations. Sixty-four percent of the patients responded to behavior therapy in these settings, and 36% achieved lasting improvements in their OCD symptoms. Implications for the impact on consumers of this seldom-used application of behavior therapy are discussed and some recommendations for future research are made.

The Skin Picking Impact Scale (SPIS) is a self-report instrument developed to assess the psychosocial consequences of repetitive skin picking. An initial 28-item scale was administered to 31 individuals with severe self-injurious skin picking and 78 individuals with non-self-injurious skin picking. Item difficulty levels and part-whole correlations resulted in a 10-item scale with good internal consistency. SPIS scores for those with self-injurious skin picking were significantly higher than for those with non-self-injurious skin picking. SPIS scores for those with self-injurious skin picking correlated with duration of daily picking, satisfaction during picking, and shame subsequent to picking, as well as Beck Depression Inventory and Beck Anxiety Inventory scores. Sensitivity and specificity analyses indicate that a scale cutoff score of 7 optimally discriminates individuals with self-injurious skin picking from those with non-self-injurious skin picking.

Background: Little is known about the longitudinal course of treatment outcome in patients with trichotillomania. The authors conducted a second follow-up assessment on a cohort of hair pullers previously studied. Method: Forty-four subjects completed a hair-pulling questionnaire and paper-and-pencil measures of hair-pulling severity and impact, psychosocial functioning, depression, anxiety, and self-esteem. Mean time elapsed between the first and second follow-up assessment was 2.5 years (index evaluation to first follow-up = 3.5 years). Results: Twenty-seven subjects (61.4%) had active treatment since the first follow-up. No significant changes in hair pulling, depression, anxiety, or psychosocial functioning were reported from first to second follow-up. Self-esteem scores significantly worsened during this period (p = .000). A trend toward worsening also existed for psychosocial impact scores. Comparison of scores at index evaluation with second follow-up still showed significant improvement over time for hair pulling (p = .001) but significant worsening in self-esteem (p = .000). Treatment and responder status were unrelated to clinical functioning, with the exception of depression and psychosocial impact. Conclusion: Although hair pullers exhibit initial improvement with treatment, scale scores plateau or worsen by second follow-up. Significant worsening in self-esteem at second follow-up may be related to the absence of further improvements in hair-pulling severity. Future research should focus on the interrelationships among self-esteem, depression, and hair pulling during treatment for this disorder.

Although body dysmorphic disorder (BDD) is receiving increasing empirical attention, very little is known about neuropsychological deficits in this disorder. The current study investigated the nature of memory dysfunction in BDD, including the relationship between encoding strategies and verbal and nonverbal memory performance. We evaluated 17 patients with BDD and 17 healthy controls using the Rey–Osterrieth Complex Figure Test (RCFT) and the California Verbal Learning Test (CVLT). BDD patients differed significantly from healthy controls on verbal and nonverbal learning and memory indices. Multiple regression analyses revealed that group differences in free recall were statistically mediated by deficits in organizational strategies in the BDD cohort. These findings are similar to patterns previously observed in obsessive–compulsive disorder (OCD), suggesting a potential relationship between OCD and BDD. Studies in both groups have shown that verbal and nonverbal memory deficits are affected by impaired strategic processing. (JINS, 2000, 6, 673–681.)

BackgroundDistressing mental imagery is hard to study experimentally in obsessive–compulsive disorder (OCD).AimsTo develop a way to assess mental imagery in OCD during functional magnetic resonance imaging (fMRI).MethodA small randomised study, controlled for type and order of mental imagery and for treatment condition (exposure therapy guided by a computer or by a therapist, or relaxation guided by audio-tape). Before and after treatment, during fMRI scanning, patients imagined previously-rehearsed scenarios that evoked an urge to ritualise or non-OCD anxiety or a neutral state, and rated their discomfort during imagery.ResultsThe method evoked greater discomfort during OCD imagery and anxiety (non-OCD) imagery than during neutral imagery. Discomfort was reduced by cancelling imagery. Discomfort during OCD imagery (but not during anxiety non-OCD imagery) fell after exposure therapy but not after relaxation.ConclusionsResults showed differences between OCD and non-OCD images and their change after successful treatment, and confirmed clinical suggestions that cancelling images reduced OCD discomfort. The method's success paves the way for further studies of mental imagery in OCD: for instance, during fMRI.

Background: Recent studies have suggested that obsessive-compulsive disorder (OCD) is a heterogeneous disorder with some forms related to tics and Tourette's disorder. The present study was undertaken to investigate the sensory phenomena in patients with OCD and/or Tourette's disorder to determine if these phenotypic features represent valid clinical indices for differentiating tic-related OCD from non-tic-related OCD. Method: We evaluated 20 adult outpatients with OCD, 20 with OCD plus Tourette's disorder, and 21 with Tourette's disorder, using a semistructured interview designed to assess several definitions of sensory phenomena reported in the literature. DSM-III-R criteria were used for the OCD and Tourette's disorder diagnoses. Results: Sensory phenomena including bodily sensations, mental urges, and a sense of inner tension were significantly more frequent in the 2 Tourette's disorder groups when compared with the OCD alone group. Feelings of incompleteness and a need for things to be just right were reported more frequently in the OCD plus Tourette's disorder group compared with the other 2 groups. Conclusion: Sensory phenomena may be an important phenotypic measure for grouping patients along the OCD-Tourette's disorder spectrum. Sensory phenomena include bodily and mental sensations. Bodily sensations include focal or generalized body sensations (usually tactile, muscular-skeletal/visceral, or both) occurring either before or during the patient's performance of the repetitive behaviors. These sensations are more frequently found in patients with OCD plus Tourette's disorder than in patients with OCD alone. Mental sensations include urge only, energy release (mental energy that builds up and needs to be discharged), incompleteness, and just-right perceptions. They are all more frequently found in patients with OCD plus Tourette's disorder than in patients with OCD alone.

Background: The present study was designed to develop a briefer screening scale of approximately 10 items which maintained the validity of the Zung Self-Rating Depression Scale in a sample similar to that attending National Depression Screening Day (NDSD), as well as a more general audience. Methods: We first administered 70 items from a variety of existing rating scales to 40 subjects who answered an ad for depressed subjects and 55 who answered an ad for non-depressed subjects, all of whose diagnoses were confirmed by the Structured Clinical Interview for DSM-IV (SCID). Based on the correlation between each item and the diagnostic criterion, we reduced the number of items to 17 which we then administered to another 45 subjects who answered an ad similar to that used for NDSD and also underwent a SCID interview. Based on these results, we arrived at the final 10-item Harvard Department of Psychiatry/NDSD scale (HANDS) with the assistance of the item-response theory. The items are scored for frequency of occurrence of each symptom over the past 2 weeks. Total scores range from 0 to 30. Results: The 10-item scale (HANDS) has good internal consistency and validity: a cutpoint score of 9 or greater gave sensitivity of at least 95% in both studies. Although specificity was lower for all scales in the self-selected population, the HANDS performed at least as well as the 20-item Zung Scale, the 21-item Beck Depression Inventory-II and the 15-item Hopkins Symptom Depression Checklist. Conclusion: The 10-item HANDS performs as well as other widely used longer self-report scales and has the advantage of briefer administration time.