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Background and objective: We previously built a weighted Depressive Health State Index (DHSI) based on 29 parameters routinely collected in an automated healthcare database (AHDB). We now propose a linear DHSI (L-DHSI) which is easier to use and to replicate across AHDBs. Methods: A historical cohort of patients with ≥1 episode of depression was identified in the Clinical Practice Research Datalink (CPRD). The DHSI was calculated for each treated episode of depression. Validation was performed by using validated definitions of remission (proxy and Patient Health Questionnaire 9 or PHQ-9) and comparing the L-DHSI between subgroups. Reliability was assessed using Cronbach's alpha. Results: Between 1 January 2006 and 31 December 2012, 309,279 episodes of depression were identified in the CPRD. Remission was observed in 5% of the patients with lowest L-DHSI scores and in 78% of the patients with highest L-DHSI scores. Although less sensitive than the weighted DHSI, the L-DHSI was reliable and relatively easy of use. The L-DHSI was highly correlated to the weighted DHSI (Spearman coefficient 0.790, p < 0.001). Conclusion: The L-DHSI represents a good balance between reliability, usability, and reproducibility. In addition, the linearity of this index allows for an easier interpretation than the original weighted DHSI. [ABSTRACT FROM AUTHOR]

Background: The Ruminative Response Scale (RRS)-short form is one of the most widely used measures of rumination, comprising ten items and two components: reflection and brooding. The aim of this study was to investigate RRS validity and reliability in a clinical sample of French patients with major depressive disorder (MDD). Subjects and methods: Outpatients with a DSM-IV-TR diagnosis of MDD were recruited from a public academic hospital in France. Depressive symptoms were evaluated by the Beck Depression Inventory, anxiety by the State-Trait Anxiety Inventory - state scale, and quality of life by the 36-Item Short Form Health Survey (SF-36) questionnaire. Confirmatory factor analyses, item-dimension correlations, Cronbach's α-coefficients, Rasch statistics, and external validity were tested. Differential item functioning analyses were performed for sex. Results: A total of 109 patients participated. The final reflection-brooding two-factor model of the RRS showed a good fit (root-mean-square error of approximation 0.041, comparative fit index 0.987, standardized root-mean-square residual 0.048) after removing one item (daily diary writing). Internal item consistency and reliability were satisfactory for the two dimensions. External validity testing confirmed that RRS scores were correlated with Beck Depression Inventory, State-Trait Anxiety Inventory, and SF-36 scores. There was no differential item functioning across sexes. Conclusion: These results demonstrated good scale reliability and validity for assessing rumination in patients with MDD. [ABSTRACT FROM AUTHOR]

Background: Treatment of schizophrenia and major depressive disorder (MDD) with atypical antipsychotics (AAPs) show improved efficacy and reduced side effect burden compared with older antipsychotic medications. However, a risk of treatment-emergent adverse events (TEAEs) remains. TEAEs are hard to quantify and perspectives on the importance of TEAEs differ across patients and between patients and physicians. The current study is a qualitative assessment that investigates TEAEs of AAPs from both patient and physician perspectives to provide better understanding of the occurrence and burden of TEAEs associated with these medications. Methods: Focus groups comprised of patients with MDD and interviews with patients with schizophrenia were conducted at two qualitative research facilities, along with a physician focus group at one of the facilities. Information collected from patients included an exhaustive list of TEAEs experienced, and the frequency and level of bother of each TEAE; from psychiatrists, information included an exhaustive list of TEAEs based on personal observations and patient report, frequency of TEAEs, clinically important TEAEs, and levels of patient-perceived bother. Standard qualitative analysis methods were used to identify, quantify, characterize, and summarize patterns found in the data collected. Results: A total of 42 patients (25 with MDD and 17 with schizophrenia) and 4 psychiatrists participated in the study. TEAEs reported as bothersome across both patients groups included cognitive issues, weight gain and/or increased appetite, low energy, extrapyramidal symptoms (EPS), and need to sleep/excessive sleep/excessive sleepiness. TEAEs considered more bothersome by patients with schizophrenia were weight gain, low energy, EPS, mental anxiety, and increased positive symptoms; those considered more bothersome by patients with MDD were cognitive issues, somnolence/sedation, and flat/restricted affect. TEAEs considered most clinically important by psychiatrists included metabolic syndrome, weight gain, neutropenia, hyperglycemia, and QT prolongation; those TEAEs considered most bothersome to patients from physicians' perspectives included weight gain, reduced sexual desire or performance, EPS, akathisia, and hormonal issues. Conclusions: The wide range of TEAEs that are both frequent and bothersome and the variation in perceived burden according to diagnosis highlight the need for a tailored TEAE-awareness approach when choosing an AAP. [ABSTRACT FROM AUTHOR]

Introduction: Vortioxetine is an antidepressant with multimodal activity which has shown efficacy in major depressive disorder (MDD) patients in six of ten short-term, randomized, placebo-controlled trials (completed end 2012). Methods: We performed meta-regression analyses to indirectly compare vortioxetine to seven marketed antidepressants with different mechanisms of action. To ensure study comparability, only experimental drug and placebo arms from placebo-controlled registration studies were included in primary analyses. The main outcomes were efficacy (standardized mean difference in change from baseline to 2 months on primary endpoint [MADRS/HAM-D]), and tolerability (withdrawal rate due to adverse events). Results: For efficacy, estimates of treatment effect (negative estimates favor vortioxetine) for vortioxetine versus comparators were: agomelatine, -0.16 (p=0.11); desvenlafaxine, 0.03 (p=0.80); duloxetine, 0.09 (p=0.42); escitalopram, -0.05 (p=0.70); sertraline, -0.04 (p=0.83); venlafaxine IR/XR, 0.12 (p=0.33); and vilazodone, -0.25 (p=0.11). For tolerability, all but one combination was numerically in favor of vortioxetine (odds ratio51), although not all differences were statistically significant: agomelatine, 1.77 (p=0.03); desvenlafaxine, 0.58 (p=0.04); duloxetine, 0.75 (p=0.26); escitalopram, 0.67 (p=0.28); sertraline, 0.30 (p=0.01); venlafaxine, 0.47 (p=0.01); and vilazodone, 0.64 (p=0.18). Sensitivity analyses did not significantly alter antidepressant effect estimates or relative ranking. Conclusion: These meta-regression data show that vortioxetine offers a comparable or favorable combination of efficacy (measured by MADRS/HAM-D) and tolerability (measured by withdrawal rate due to adverse events) versus other antidepressants in registration studies in MDD. Alternative methods like mixed-treatment comparison and inclusion of all randomized studies and active reference arms may provide complementary information to this analysis (more evidence but also more heterogeneity. [ABSTRACT FROM AUTHOR]

Objective. Escitalopram is the most selective of the serotonin reuptake inhibitors. Methods. We review all the clinical trials (three pivotal placebo-controlled trials with citalopram as an active reference, one long-term non-inferiority study and one head-to-head superiority study) that include citalopram as an active reference in major depressive disorder (MDD), and studies that evaluate the cost-effectiveness of the two drugs. Results. In two of the pivotal studies and in the long-term study, escitalopram was numerically better than citalopram in reducing Montgomery-Åsberg Depression Rating Scale (MADRS) scores from baseline, with comparative tolerability. Meta-analyses of these studies showed statistically significant differences in favour of escitalopram in terms of reducing MADRS and increasing response. This effect was particularly apparent in patients with higher baseline MADRS scores. These trends were confirmed in a head-to-head study, which clearly demonstrated the superiority of escitalopram compared with citalopram on primary and secondary endpoints. The difference between treatments was clinically relevant. Cost-effectiveness analyses demonstrated that although escitalopram has a slightly higher unit cost than generic citalopram, expected direct medical and productivity- related costs were lower with escitalopram than citalopram. Conclusion. On the basis of these results, escitalopram was concluded to be more clinically effective and more cost-effective than citalopram for the treatment of MDD, with a similar tolerability profile. [ABSTRACT FROM AUTHOR]

Abstract: Objective: The aims of this study were as follows: 1. to assess the quality of life (QoL) of caregivers of individuals with affective disorders (major depressive disorder and bipolar disorder); 2. to compare QoL levels with those observed in caregivers of individuals with schizophrenia and in the general population; 3. to determine the impact of sociodemographic and clinical factors on the caregivers'' QoL. Methods: Data were collected from the psychiatric departments of a French public teaching hospital. QoL was measured with the SF-36 questionnaire. The QoL of 232 caregivers of individuals with affective disorders was compared with 246 caregivers of individuals with schizophrenia and 232 French age–sex-matched controls. Results: Caregivers of individuals with affective disorders experienced lower QoL levels than French age–sex-matched controls. The most severe impairment concerned psychological distress, social and role disability due to emotional problems (SF36-mental composite score=38.2). In contrast, caregivers of individuals with affective disorders reported higher SF36 dimension scores than caregivers of individuals with schizophrenia. Among caregivers of individuals with affective disorders, women (p=0.010), parents/family or spouse (p=0.017), caregivers living in the same home (p=0.003) and caregivers of individuals with MDD (p=0.005) were significantly associated with a lower SF36-mental composite score. Conclusion: The QoL of caregivers of individuals with affective disorders is seriously impaired, mainly because of an altered psychological or mental well-being and social life. QoL adds interesting and complementary information to information that has been traditionally collected (burden, stress, perceived stigma) and facilitates the identification of specific needs that should be addressed in support groups for caregivers. [Copyright &y& Elsevier]