Search

Background Clinician-administered measures of negative symptoms may not capture patients' subjective experiences. The Self-Evaluation of Negative Symptoms (SNS) has shown good psychometric properties when used in outpatients with higher-level functioning schizophrenia. We aimed to evaluate the psychometric properties of the SNS in low functioning participants with treatment-resistant schizophrenia (TRS). Methods Participants were assessed using the following measures at two time-points; time-point 1: SNS, Wide Range Achievement Test, 4th Edition Reading Subtest (WRAT-4), and Brief Assessment of Cognition in Schizophrenia (BACS). Time-point 2 (within a week of time-point 1): SNS, Negative Symptom Assessment 16 items (NSA-16), Scale to Assess Unawareness in Mental Disorder-Abbreviated (SUMD-A), Clinical Global Impression Severity Scale (CGI-S), Simpson Angus Scale (SAS), Calgary Depression Scale for Schizophrenia (CDSS), and the Patient Feasibility Questionnaire. Results Fifty participants with TRS were enrolled, a mean age of 43.8 years (SD = 11.19, min = 25, max = 64), a mean IQ of 80.62 (SD = 17.12, min = 65, max = 110), and a mean BACS Composite T-Score of 14.08 (SD = 17.16, min = −27, max = 49). Participants responded to SNS prompts with moderate consistency across two time-points. There were no significant correlations between the SNS and the NSA-16 Global Symptom score (Pearson r = 0.207, p = .150, Spearman r = 0.101, p = .483), NSA-16 Global Functioning score (Pearson r = 0.209, p = .145, Spearman r = 0.126, p = .384), nor the NSA-16 total score (Pearson r = 0.149, p = .302, Spearman r = 0.116, p = .421). However, when participants were stratified by BACS Composite T-score, there was a significant positive correlation between the SNS total and the NSA-16 Global Functioning score (Pearson r = 0.500, p = .048, Spearman r = 0.546, p = .029) among participants who demonstrated higher cognitive functioning. Conclusion Participants with TRS and low functioning were able to respond to questions on the SNS regarding their subjective assessment of negative symptoms. However, self-reported and clinician-rated negative symptoms were not equivalent, except in a subgroup with higher cognitive functioning. This discrepant self-reporting appeared to relate to their low levels of insight and cognitive impairments.

This review of research utilizing the Schizophrenia Cognition Rating Scale (SCoRS) outlines the development, evaluation, validation, and implementation of the SCoRS to assess whether the scale meets the criteria as a functional co-primary as defined by the MATRICS-CT initiative. Interview-based co-primary assessments should be: 1) practical and easy to administer for a clinician or researcher; 2) validated in individuals with schizophrenia; 3) contain the relevant areas of cognition and functioning applicable to schizophrenia; 4) able to assess all phases and severity levels of schizophrenia; 5) capable of monitoring disease progression; 6) minimal burden to patients; and 7) sensitive to assess treatment effects. A review of the literature was conducted to present information on the development, psychometric properties and usage of the SCoRS. Review of the development of the SCoRS followed the parameters outlined for scale development on content expert validation and feedback. The SCoRS shows good psychometric properties in various studies, and demonstrates low burden on clinicians and patients. The items measure global concepts that do not require notable cultural modification, making international use feasible. While multiple performance-based tests in cognition and functional outcomes are available, there is a need for a multi-domain, interview-based assessment of cognitive progression and treatment response in clinical trials. The SCoRS appears to meet many of the criteria for an optimal co-primary measure for schizophrenia cognition clinical trials as defined in the MATRICS-CT initiative.

The MATRICS Consensus Cognitive Battery (MCCB) was developed to assess cognitive treatment effects in schizophrenia clinical trials, and is considered the FDA gold standard outcome measure for that purpose. The aim of the present study was to establish pre-treatment psychometric characteristics of the MCCB in a large pooled sample. The dataset included 2616 stable schizophrenia patients enrolled in 15 different clinical trials between 2007 and 2016 within the United States (94%) and Canada (6%). The MCCB was administered twice prior to the initiation of treatment in 1908 patients. Test-retest reliability and practice effects of the cognitive composite score, the neurocognitive composite score, which excludes the domain Social Cognition, and the subtests/domains were examined using Intra-Class Correlations (ICC) and Cohen's d. Simulated regression models explored which domains explained the greatest portion of variance in composite scores. Test-retest reliability was high (ICC=0.88) for both composite scores. Practice effects were small for the cognitive (d=0.15) and neurocognitive (d=0.17) composites. Simulated bootstrap regression analyses revealed that 3 of the 7 domains explained 86% of the variance for both composite scores. The domains that entered most frequently in the top 3 positions of the regression models were Speed of Processing, Working Memory, and Visual Learning. Findings provide definitive psychometric characteristics and a benchmark comparison for clinical trials using the MCCB. The test-retest reliability of the MCCB composite scores is considered excellent and the learning effects are small, fulfilling two of the key criteria for outcome measures in cognition clinical trials.

Background Studies have shown a convergence of neural systems implicated in cognitive control and social emotional functions with mechanisms involved in emotion regulation, awareness, and impulsive aggression. In a sample of patients with a history of aggression, we examined the association of cognitive and social cognitive functions with emotion regulation capacity, emotional awareness, impulse control, and aggression. Methods Participants were 78 individuals with schizophrenia or schizoaffective disorder that participated in a cognitive training study. Emotion regulation capacity was indexed by obtaining participants’ heart rate variability (HRV), respiration, and skin conductance while participants viewed pictures selected from the International Affective Picture System (IAPS). Three blocks of pictures were presented—a neutral block depicting pictures of everyday objects preceded by audio recordings of their description; an emotionally-evocative block preceded by their description, and a reappraisal block of emotionally-evocative pictures preceded by reappraisal statements. A subset of participants (N=37) completed the emotion regulation task. The MATRICS Consensus Cognitive Battery (MCCB), the Reading the Mind in the Eyes Task (Eyes Task), and the Emotion Recognition-40 (ER-40) were administered to assess cognitive functioning, mentalizing, and facial affect recognition respectively. Negative affectivity was captured using the Positive and Negative Affect Schedule (PANAS) whereas aggression was measured with the Taylor Aggression Paradigm (TAP) and the Overt Aggression Scale Modified (OAS-M). In a smaller subsample of 12 individuals, we performed analyses of activation patterns during the performance of the emotion regulation task. Regions of interest (ROI) included the dACC, DLPFC, VLPFC, vmPFC, left and right amygdala, and the subcallosal cingulate. We created a regional mask of the cognitive control and emotional appraisal regions for event-related fMRI. Results There were inverse associations between performance on the MCCB and the Eyes Task and indices of emotion regulation capacity—in particular, significant associations were obtained with Low Frequency/High Frequency HRV ratio (r=-0.324, p There were inverse associations between activation within the event-related regional mask and low frequency/high frequency heart rate variability ratio at rest (r=-0.504, p=0.095) and during the viewing of emotionally-evocative pictures (r = -0.264, p=0.36). Associations with HRV were especially remarkable for the dorsomedial, ventrolateral, and right amygdala regions. Remarkably, increased activation in the regional mask when reappraisal statements were provided with emotionally-evocative pictures was inversely correlated with the life history of aggression LHA (r=-0.32, p=0.28, n=14) and OAS (r=-0.284, p=0.34, n=14) aggression scores. This pattern was present when the dACC, right and left amygdala, DLPFC, VLPFC, and the subcallosal cingulate were set as the seed region. Discussion The results show an association between cognitive functions and emotion regulation capacity indexed by measuring physiological arousal during the performance of the picture viewing task. Emotion regulation capacity also showed significant association with aggression. Deficits in cognitive and social cognitive abilities may contribute to and be viable targets for improving emotion regulation capacity and decreasing aggression risk.

BACKGROUND: Clinical trials for schizophrenia are increasingly using electronic methods to collect patient-reported outcomes (ePRO). Hence, several ePROs have been developed to better understand patients’ experience with their own illness. Lack of insight into illness is a core feature of schizophrenia that is multidimensional,and related to poor compliance with treatment and relapse. Assessing insight into illness via an ePRO, and attaining patient perception may provide supplemental information to the clinician as data is collected in real-time to facilitate functional and risk assessment. Core questions are whether it is feasible for patients with schizophrenia to complete an ePRO on their smartphone, and will the results obtained from patient’s perception of insight compare to clinician assessed insight, and passive digital biomarkers of psychiatric morbidity. The aim is to (1) develop a short, multidimensional self-report measure of insight (Awareness of Insight Scale, AIS), (2) assess validity and reliability, and (3) evaluate feasibility in schizophrenia study context. METHODS: A Delphi method was used to facilitate expert participation and ensure face and content validity for development of the AIS. The SUMD and SCI-PANSS G12 Lack of Insight were used as a reference for scale development. A new scale with 8 items incorporating David’s (1990) dimensions of insight was developed consisting of: (1) awareness of having a mental illness, 2) relabel unusual mental events as pathological, and 3) adherence to treatment. The scale was presented as a smartphone app for 6 months via a parent study assessing passive digital biomarkers of psychiatric morbidity (Mindstrong Health). Feasibility was assessed based on the rate of completion of the ePRO. Internal consistency, test-retest reliability and validity were assessed by comparing with PANSS: G12 and Disorganization Factor in a sample of 16 outpatients. The ePRO was designed with push messages suggesting patients complete the scale once per week. RESULTS: The 8 items selected for inclusion in the AIS assessed awareness of psychiatric illness, need to take medications, attributing being sad or upset to unusual experiences, and belief that s/he is always correct. Of the 22 subjects enrolled, data is presented for 16 subjects, as the remaining 6 subjects were not active on their smartphones. Of the 16 subjects, all completed at least 2 weeks of AIS assessments on their smartphone with 68.75% completing all weekly assessments since enrollment with an average of 3.66 minutes to complete. Internal Consistency was high (α = 0.79). Preliminary findings show scores on AIS correlated with PANSS G12 (r = 0.51, p = 0.03) and with the PANSS Disorganization Factor (r = 0.39, p = 0.04). Test-retest reliability are moderate with ICCs = 0.72. DISCUSSION: Preliminary findings show the AIS is a short, reliable and valid measure of insight in schizophrenia. Findings support its feasibility in a small sample of outpatients with chronic and treatment resistant schizophrenia with multiple relapses.

BACKGROUND: A patient’s readiness for discharge can be assessed from the perspectives of the clinician, patient, and family. Criterion-based assessment by the clinician is the most commonly reported method, but there is no ecologically valid method available to assess readiness for discharge while in the hospital. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) is a novel game-based program, that provides a sequence of objectives related to activities involved in a multi-level shopping task. The aim of the present study was (1) to examine the feasibility of administering the VRFCAT in a population of very low functioning patients with chronic schizophrenia, (2) to relate the performance of the study patients to standardized VRFCAT performance data of higher functioning patients (Keefe et al. 2016), (3) to assess the concurrent validity of the VRFCAT in this population, and (4) to correlate the performance measures to measures of community adjustment 4 weeks after hospital discharge. METHODS: The VRFCAT was administered after informed consent to inpatients with DSM 5 diagnosis of chronic schizophrenia, who were eligible for discharge from a long-term inpatient psychiatric facility. Independent variables included the VRFCAT time to completion (adjusted total time), number of errors on 12 VRFCAT objectives, and the number of times that an individual failed to complete a task (forced progression). The SLOF, the UPSA-B and the PSP were completed for concurrent validity. Patients were followed for one month after their discharge to assess the level of their community adjustment as measured by the SLOF, the UPSA-B and the PSP. RESULTS: Of the 80 subjects enrolled, a total of 72 subjects had evaluable data with a mean age of 41.23 years (SD = 10.11). 55.56% of subjects also had an axis I substance use diagnosis. The mean level of education was 9.89 (SD = 2.69) and 56.94% of patients had a history of incarceration. When compared to higher functioning patients’, participants performed 2.5 standard deviations below the mean for the adjusted total time (Mean T Score = 24.89, SD = 16.56), total errors (T = 24.11, SD = 22.69), and 2 SDs below the mean for total forced progressions (T = 29.56, SD = 14.311). VRFCAT test-retest reliability showed unchanged mean T scores: total time (T Score = 23.11, SD = 16.23), total errors (T = 23.56, SD = 22.00). Pearson correlations at baseline for 4 of 12 VRFCAT objectives with concurrent SLOF Activities (Pay for the Bus, Shop for Groceries, Pay for Groceries), and Work Skills (Shop for Groceries, Pay for Groceries) domain scores were statistically significant (p < 0.001). At 4-week follow-up, significant correlation was found with the change in PSP Domain A of socially useful activities and change in VRFCAT Adjusted Total Time [r = 0.586, p = 0.044]. There were no significant correlations between the SLOF and VRFCAT for change from baseline. There was no difference in VRFCAT scores between the subjects who were re-hospitalized and those who missed clinic appointments. Non-relapsing participants had a higher score on adjusted total time, which indicates worst functional outcomes. DISCUSSION: Results indicate that the VRFCAT is feasible in schizophrenia patients with low levels of functioning and delivers meaningful functional concurrent data. Both concurrent and test-retest validity were good. The VRFCAT performance level was not useful for measurement of readiness for discharge for clinical purposes.

BACKGROUND: The association between schizophrenia and violence is an important issue in psychiatry. The impact of several factors (social cognition, neurocognition, alexithymia, emotion regulation capacity, and the therapeutic milieu) on aggression in schizophrenia creates an opportunity for the development and evaluation of novel treatments for aggression. Previous studies show that cognitive remediation training (CRT) and social cognitive training (SCT) help to decrease hostility. The parent study examined whether cognitive training leads to improvements in cognition emotion regulation capacity, and impulse control in participants with a history of impulsive aggression. The current study examined the effectiveness of CRT alone versus a combination of CRT and SCT in terms of emotion recognition and cognitive improvement. METHODS: The study recruited participants with schizophrenia or schizoaffective disorder with a past year history of at least one or more violent acts or a significant lifetime history of aggression as indicated by a score of 5 or more on the Life History of Aggression (LHA) interview from two inpatient sites (Manhattan Psychiatric Center and New York Hospital, Westchester Division). Participants were randomized to two groups of 36 one-hour sessions. Participants in the control group had 24 sessions of CRT (BrainHQ) and 12 sessions of Encyclopedia readings. Participants in the treatment group had 24 sessions of CRT (BrainHQ) and 12 sessions of computerized SCT (MindReading). To assess neurocognition, mentalizing, and facial affect recognition abilities, participants were administered the MATRICS Consensus Cognitive Battery (MCCB), Reading the Mind in the Eyes Task (Eyes Task), and the Emotion Recognition-40 (ER-40) respectively. Negative emotionality was captured using the Positive and Negative Affect Schedule (PANAS). RESULTS: The study data included 49 completers and 5 intent-to-treat samples, with 24 and 25 per group, respectively (CRT+ SCT and CRT alone). Results indicated no significant differences between groups at baseline. Significant overall improvements were observed in the ER-40 for all subjects across time (Mean Time 1 = 25.06 (SD = 25.023), Time 2 Mean = 30.86 (SD = 6.849), p < 0.001), the Mind in the Eyes Test - Revised (Time 1 Mean = 19.70 (SD = 7.407), Time 2 Mean = 26.15 (SD = 7.830), p < 0.001), and the PANAS Negative affect Score (Time 1 Mean = 29.40 (SD = 11.836), Time 2 Mean = 18.47 (SD = 2.688), p < 0.001). Both cognitive groups showed improvements from baseline on the composite cognition score of the MCCB composite (F (1,47)=74.51, p

Background An individual’s mental health is best captured by considering the overall associations of biological, behavioral, and social functions that comprise the framework of individual experience. As such, accessing data on various health indicators concurrently can influence prediction of disease progression or change in response to treatment. Data generated passively by smartphones to measure human behavior has generated significant research interest and has increasingly been utilized in psychiatric disorders. In schizophrenia, passive and continuous assessment of how an individual uses their mobile device may give rise to clinically useful markers that can be used to improve treatment processes, adapt treatment choices, identify early risk for relapse to initiate clinical intervention, and develop new clinical models. A promising approach is to leverage current advances in mobile technology, data analytics and machine learning to enable automated and fast phenotyping of digital data. . In this context, the workflow for phenotyping (passive data collection → data storage and curation → trait extraction → machine learning/classification → models/apps for decision support) has to be carefully designed and efficiently executed to minimize resource usage and maximize utility. Digital phenotyping can be used in conjunction with standard care to reduce time to recognition and acknowledgement that worsening of a symptom needs to be addressed, to reduce time to receiving appropriate level of care, to increase ability to analyze and collect data from a variety of sources to improve mental health needs assessment and delivery of services, and to advance outcome measurement through comparison of passive and active data sets. Aim The aim of this pilot study is to test whether a smartphone digital phenotyping application can help detect early signs of treatment failure or response in individuals with chronic schizophrenia after discharge from hospital. Methods 17 individuals with DSM-5 schizophrenia were provided with a smartphone and digital phenotyping app, MindStrong Health app, following discharge from an inpatient psychiatric facility. The participants were followed for 6 months with monthly rater administered evaluations assessing neurocognition (Brief Assessment of Cognition in Schizophrenia (BACS)), symptomatology (PANSS; CGI-S/I), quality of life (SF-36), healthcare utilization, alcohol/drug use, level of clinical insight and depression (Calgary Depression Rating Scale, CDSS). Digital phenotyping data included gestures (swipes, taps, other), orientation (the way the phone is pointing), acceleration (sudden movements of the phone), keystroke patterns with characters encoded, number of calls made, number of emails sent, number of text messages sent, and location information from the GPS. Predictive models were built using multiple machine learning techniques - random forest plots, linear regression and gradient boosting, to predict the target scores based on phone usage patterns. Results Of the 17 enrolled participants, 10 provided analyzable data (i.e., had at least 22 target days with data). There was a gradual reduction of passive data generation due to either non-use of the smart phone or due to non-recharging of the device. The mean PANSS score was 80.12 (14.56). BACS scores corresponding to motor speed (token motor task), verbal fluency (category instances, letter fluency), and attention and processing speed (symbol coding) were found to be highly correlated with a composite digital phenotyping marker while scores on the PANSS or CDSS were not. Discussion The study provides a basis for using smartphone-base mobile apps to use as an augmentation within clinical practice to gather further information on patients outside the clinic setting, focusing on their behavior in the ‘real world.’ In particular, the cognitive data derived from the digital device correlated well with rater administered traditional cognitive ratings. Collecting digital data can provide a much needed window into the lives of patients in between normally scheduled visits, while minimizing costs and inconvenience to the patient. Studies with larger sample sizes are required to assess relationships with relapse, rehospitalizations and treatment failure.

Background: Negative symptoms and cognitive deficits have a substantial predictive value for functional deficits and recovery in schizophrenia. However, the relationship between negative symptoms and cognitive abnormalities is unclear possibly due to the heterogeneity of negative symptoms. This study used the model of expressive and experiential negative symptoms subfactors to decrease this heterogeneity. It examined these subfactors and cognition before and after treatment with computerized cognitive remediation training (CRT) in chronically-hospitalized individuals with psychosis and predominant negative symptoms. Methods: Seventy-eight adult participants with a DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder were enrolled in a 12-week CRT program. Assessments of demographic and illness variables, baseline and endpoint assessments of psychopathology (Positive and Negative Syndrome Scale) and cognition (MATRICS Consensus Cognitive Battery - MCCB) were conducted. Results: The baseline expressive negative subfactor was associated with Processing Speed (r = −0.352, p ≤ 0.001) and Reasoning/Problem Solving (r = −0.338, p ≤ 0.001). Following CRT, there was a significant decrease in the experiential negative subfactor (p

BACKGROUND: The risk of impulsive aggression is elevated in schizophrenia and reducing the risk of violent acts in patients is a critical to their overall functional recovery. Cognitive training interventions have been shown in previous studies to decrease the risk of aggression. The current study examined whether cognitive training leads to improvements in emotion regulation and impulse control, two contributors to aggression. METHODS: The study recruited participants (N=90) with schizophrenia or schizoaffective disorder with a past year history of one or more violent acts or a significant lifetime history of aggression as indicated by a score of 5 or more on the Life History of Aggression (LHA) interview. Participants were randomized into one of two cognitive training groups—a cognitive remediation training plus social cognition training (CRT+SCT) group versus CRT alone. The study primary outcome—aggression—was measured using the Overt Aggression Scale (OAS), Point Subtraction Aggression Paradigm (PSAP), and the Taylor Aggression Paradigm (TAP). Emotion Regulation Capacity was indexed by obtaining participants’ heart rate, respiration, and skin conductance while participants viewed pictures selected from the International Affective Picture System (IAPS). Negative emotionality was captured using the Positive and Negative Affect Schedule (PANAS). The Go/NoGo task was used to measure impulse control. RESULTS: Participants were 35.23 years old (SD=9.99) and had completed 11.82 (SD=1.94) years of education. Most were men (83.5%) and African-American (44.4%). All participants had a past year history of violence and an LHA score of 19.57 (SD=5.70). The study data included 49 completers and 5 intent-to-treat samples. Both cognitive training groups showed reductions in negative affectivity scores from baseline but differences were minimal between both groups. Both groups demonstrated pre-to-post reductions in their Low Frequency/High Frequency heart rate variability ratio (Cohen’s d=-0.83) and skin conductance (Cohen’s d = -0.48). Pre-to-post differences between the two training groups were minimal. Both groups demonstrated large pre-to-post reductions in misses on the No-Go trials of the Go No-Go Task (d =-1.74). Reductions were greater in the CRT+SCT than the CRT only group (d=0.27) suggesting that the CRT+SCT group show greater improvements in impulse control after cognitive training. Both groups also showed pre-to-post reductions on the TAP, the PSAP, and the OAS. Differences favored the CRT+SCT group on TAP (F(1,37)=3.99, p

BACKGROUND: Few studies have compared clinical evaluations of negative symptoms to those done by patients. Self-report tools may better reflect the patients’ subjective experience. The Self-Evaluation of Negative Symptoms (SNS; Dollfus et al., 2015), a 20-item scale, was developed to assess the subjective experience of negative symptoms by schizophrenia patients. Dollfus et al (2015) found that the SNS had good psychometric properties and demonstrated that the patients’ ratings were highly correlated with observer ratings. Patients included in the Dollfus et al (2015) study were stable outpatients with a high level of functioning. It remains to be explored whether patients with a lower level of functioning can identify their negative symptoms in a reliable fashion. Our goals were (1) to examine if chronic, low functioning patients can complete the instrument without assistance, potentially providing more immediate insight into their internal perception of negative symptoms and (2) to examine the correlation of their subjective reports with the research assessment of negative symptoms. METHODS: Stable in- and outpatients who met DSM-5 criteria for schizophrenia spectrum disorder were included in the study. After consenting, patients self-administered the SNS assessment at two time points, separated by one week, with other rater-administered concurrent evaluations: the 16-Item Negative Symptom Assessment (NSA-16), a validated clinical assessment for negative symptoms, the CGI-S, WRAT, BACS, and CDSS. RESULTS: A total of 50 subjects with a mean age of 43.71 years (SD = 11.03), 86% male, 64.81% African American, with a mean chlorpromazine equivalency dose of 869.22 (SD = 59.69). Mean premorbid IQ was 79.71 (SD = 17.51) determined by WRAT Standard Total, and BACS Composite T Score mean was 33.56 (SD = 12.11). Cronbach’s coefficient of the SNS (α = 0.903) showed good internal consistency. The intraclass correlation coefficients (ICCs) between SNS time point 1 and SNS time point 2 showed good inter-rater reliability (ICC = .849, 95% CI [.739, .928]. Of the 20 SNS items, significant correlations with the NSA-16 Global Level are reported for only 2 items: “I don’t take any great pleasure in talking with people” (r = 0.65, p < 0.001), and item “I am not interested in having sex, with “Sexual interest” (r = 0.58, p = 0.003). There was a significant difference in the SNS total score between Visit 1 (t(53) = 9.11, p < 0.001) and Visit 2 (t(53) = 8.23, p < 0.001). Significant correlations were also identified for SNS Item “I don’t take any great pleasure in talking with people” and the SUM-D Awareness of Asociality item (r = 0.564, p = .005) and SNS Item “I am not interested in going out with friends or with a family member” and the SUM-D “Awareness of mental disorder” (r = 0.578, p = .004). DISCUSSION: This study shows that patients with negative symptoms can self-administer a patient reported outcome measure. However, the relatively low correlation between the self-reported SNS items and the research rated NSA-16, suggests that the agreement between self-rating and observer-rating of negative symptoms in patients with chronic schizophrenia is rather low, except for two items. Patients also evaluated the severity of their negative symptoms rather differently one week apart suggesting different subjective assessment levels by patients at different times. It appears that patients with chronic schizophrenia and low levels of functioning are not able to self-evaluate their negative symptoms and give variable answers on repeat self-evaluations.

Objectives Cognitive remediation therapy (CRT) has shown significant improvement in cognition in schizophrenia. However, effect sizes of CRT have been reported to be modest raising the issue how to augment the effects of CRT on neurocognition and social cognition. Our aim was to examine whether the addition of computerized social cognition training would enhance the effects on neurocognition and social cognition as compared to CRT alone. Methods This is a 12-week, parallel group trial of 131 in- and out-patients with schizophrenia randomized to CRT (COGPACK or Brain Fitness) with computerized social cognition training (MRIGE), or CRT alone for 36 sessions. Participants were assessed at baseline and after 12 weeks of treatment. Assessments included neurocognition, social cognition, psychopathology, and functioning. Results The combined intervention, CRT + MRIGE, showed greater improvements in the MCCB indices of Visual Learning, Working Memory, Reasoning and Problem-Solving, and the neurocognitive composite score compared to CRT alone (Bonferroni adjusted p = 0.004, p = 0.005, p = 0.01, respectively), as did social cognition measures (Bonferroni adjusted p = 0.006, p = 0.005, respectively). Conclusions Supplementing CRT with computerized social cognition training produced greater benefits in neurocognition, including visual learning, memory, executive functions, and social cognition relative to cognitive training alone. These findings favoring the combined training may be contributed to both the greater overall amount of cognitive practice, as well as the specific cognitive functions engaged by the social cognition training.

Background The Positive and Negative Syndrome Scale (PANSS) assesses multiple domains of schizophrenia. Evaluation of each of these domains was conducted to assess differences in the characteristics of psychopathology and their relative predominance in sub-populations. Method Subjects (N = 1,832) with DSM-IV schizophrenia were represented in three sub-populations: First Episodes, n = 305, Chronic Inpatients, n = 694, and Ambulatory Outpatients, n = 833. Nonparametric Item Response Analysis (IRT) was performed with Option Characteristic Curves (OCC), Item Characteristic Curves (ICC), slopes and item biserial correlation. Items were characterized as Very Good, Good, or Weak based on specified operational criteria for item selection. Results First episode patients were represented by negative, disorganized hostility and anxiety. Some negative domain items (Poor Rapport, Passive/Apathetic Social Withdrawal) and most positive domain items were scored as Weak. For chronic inpatients, all items of the anxiety domain and some items of the positive domain (Suspiciousness/Persecution, Stereotyped Thinking, Somatic Concerns) were Weak; for all other domains, items were Very Good or Good. For ambulatory outpatients, most items in the anxiety and hostility domain were scored as Weak. The majority of PANSS items were either Very Good or Good at assessing the overall illness severity: chronic inpatients (73.33%, 22 items), first episodes (60.00%, 18 items), and only 46.67% (14 items) in the ambulatory group. Conclusion Findings confirm differences in symptom presentation and predominance of particular domains in subpopulations of schizophrenia. Identifying symptom domains characteristic of subpopulations may be more useful in assessing efficacy endpoints than total or subscale scores.

Background The Self-Evaluation of Negative Symptoms (SNS), a 20-item self-rating scale,was developed to assess the subjective experience of negative symptoms by schizophrenia patients. The reliability and validity of the translated French version of the SNS was examined in a sample of outpatients in an US site with schizophrenia and schizoaffective disorders (Dollfus et al., 2015). The author found that the SNS had good psychometric properties and demonstrated that the patients’ ratings were highly correlated with observer ratings, which contradicts the expected lack of reliability of patient reported symptoms in patients with schizophrenia. However, the patients included in the study were stable outpatients with high levels of functioning as compared to lower functioning patients. It remains to be explored whether patients with lower levels of functioning are equally able to identify their negative symptoms in a reliable fashion. The aim of the present study was to first evaluate the reliability of the novel tool of self-evaluation of Negative Symptoms (SNS) and to examine its correlation with observer ratings of negative symptoms in a sample of inpatients with ICD 10 schizophrenia or schizo-affective disorder who function at a low level of overall cognition. It was our goal to examine if chronic, low functioning patients are able to complete the instrument without assistance, providing clinically meaningful information with respect to their own perception of negative symptoms. Methods Patients who met DSM-5 criteria for schizophrenia or schizoaffective disorder were included in the study. All patients will provide written informed consent. Patients were administered the SNS assessment at two time points, separated by 1 one week, followed by other concurrent evaluations: the 16-Item Negative Symptom Assessment (NSA-16), a validated clinical assessment for negative symptoms, the CGI-S, WRAT, BACS, and the CDSS. To examine the internal consistency of the SNS. Cronbach’s alpha was calculated for the 20 items and the 5 sub scores at both times. Correlation analyses were performed to examine the convergent validity of the SNS with the observer rated negative symptom scale. Convergent and discriminant validities were tested with Pearson’s correlations. The test-retest reliability of the SNS will be tested by intraclass correlation coefficients (ICCs). Results Fourteen patients with schizophrenia or schizoaffective disorder according to DSM-5, and a mean age of 43.00 (12.48) were evaluated. 66.67% of subjects were African American. Cronbach’s coefficient of the SNS (α = 0.791) showed good internal consistency. The SNS did not show significant correlations with the NSA-16 (r = 0.207, p = 0.497), the NSA global score (r = 0.390, p = 0.296), nor the Clinician Global Impression on the severity of negative symptoms (r = -0.264, p = 0.383). SNS scores did not correlate with level of insight as measured by the SUMD (r = -0.51, p = 0.870), Motor Functioning deficits as measured by the SAS (r = 0.227, p = 0.456). The intrasubject reliability of the SNS revealed good intraclass correlation coefficients (ICC = 0.780). Test-Retest was significant at 0.791, p = 0.004, with a significant change at t(12) = 3.923, p = 0.002. Discussion Our pilot study suggests that the agreement between self-rating and observer-rating of negative symptoms in patients with treatment resistant schizophrenia is rather low as. Patients also evaluated the severity of their negative symptoms rather differently. Reasons for this discrepancy will be discussed, in particular, in the context of low levels of illness insight as well as the psychometric qualities if the SNS.

Background: Following both meta-analysis and extensive resequencing, the single-nucleotide polymorphism of allele A, rs1344706, located in intron 2 of the zinc-finger protein gene ZNF804A, continues to be the common variant most strongly associated with schizophrenia risk (P = 1.1_10–13). ZNF804a is highly expressed in adult brain and functional effects on both protein expression, and altered DNA–protein interaction have been reported. In addition, the ZNF804A rs1344706 A allele has recently been reported to be associated with worse clinical outcome. We were interested in examining whether another proxy for worse clinical outcome, the Positive and Negative Syndrome Scale (PANSS) excitement factor, is associated with a ZNF804a genotype. We hypothesized that a single-nucleotide polymorphism in ZNF804a could be associated with impulsivity. The aim of this study was to assess the association of a single-nucleotide polymorphism rs1344706 with the PANSS excitement factor.

Background: The Positive and Negative Syndrome Scale (PANSS) is a widely used assessment for patients with schizophrenia across clinical and research settings. This scale allows the classification of the psychotic symptoms to better understand the psychopathology in patients with schizophrenia. There are no available data on the different components of psychopathology in Arab patients with schizophrenia. Objectives: This study examined the factor structure of the validated Arabic version of the PANSS in a sample of Arab patients with schizophrenia. Methods: The Arabic version of the PANSS was administered to 101 patients with schizophrenia, and principal component analysis (PCA) was carried out after the cross-cultural adaptation and validation of this version. Results: This sample had more males (66.3%) than females (33.7%) with a mean age of 35.03 years (SD = 9.99). PCA showed that 28 items loaded on 5 components: cognitive, negative, excited, depressed and positive. These factors explained 63.19% of variance. The 2 remaining items, grandiosity and somatic concerns, did not load well on any of these components. Conclusion: Our results support the common 5-dimension PANSS model shown in other cultures with different languages. Nevertheless, there were minor differences, which could reflect cultural or semantic differences.

This study aims to examine the effects of change in neurocognition on functional outcomes and to examine predictors of change in social functions following a 12-week course of cognitive remediation in patients with schizophrenia and schizoaffective disorder with severe cognitive impairments.Level of social functioning was assessed using a performance based measure of functional capacity (PSP) in patients prior to and after the completion of 12-week cognitive remediation treatment (CRT). Participants completed a neuropsychological battery (MCCB-MATRICS) and clinical measures at both time points.63 subjects with a mean age of 41.4 (SD=12.2) and with 12.2years of education (SD=2.4) were enrolled. There were significant improvements in overall PSP score from baseline to endpoint (p=0.021) as well as in PSP domain A (socially useful activities) (p≤0.001), domain B (personal and social relationships) (p=0.009), and domain D (disturbing and aggressive behaviors) (p=0.003). There was a significant improvement in the composite MCCB score (p=0.020) and the Working Memory (p0.046). Stepwise logistic regression yielded a significant association for baseline Visual Learning (Wald=6.537, p=0.011, OR=1.195), Speed of Processing (Wald=4.112, p=0.043, OR=0.850) and level of PANSS positive symptoms (Wald=4.087, p=0.043, OR=0.739) with PSP overall improvement.Faster speed of processing, better visual and verbal learning and less prominent positive symptoms were associated with greater functional improvement after a systematic cognitive intervention within a rehabilitative setting.

Background The metabolic syndrome (MetS) and cognitive impairments are common in schizophrenia. Both are associated with poor outcomes, which have received increasing medical and mental health attention. Whether MetS is associated with impaired cognitive functions in schizophrenia has not been thoroughly addressed. The aim of this study was to compare the association between patients with and without MetS and its contributing components with neurocognitive performance. We hypothesized that patients with MetS would be associated with more impaired cognitive performance. Methods 159 patients with schizophrenia or schizoaffective disorder, with available metabolic data were included in the study. Patients were classified as either having or not having MetS as defined by the NCEP Adult Panel-III criteria. All patients completed neurocognitive and metabolic tests. Results Of the 159 patients, 43.34% had MetS. Patients without the MetS performed significantly better on tests measuring processing speed (p = 0.050), attention/vigilance (p = 0.040), working memory (p = 0.041) and problem solving/reasoning (p = 0.050) compared with those with MetS. Patients with MetS showed significantly lower cognitive domain scores. After Bonferroni correction greater waist circumference was associated with lower scores on attention/vigilance (β = − 0.551; p ≤ .0083), HDL was positively associated with scores on attention/vigilance (β = 0.900, p ≤ .0083) and higher triglycerides were associated with lower scores on attention/vigilance (β = − 1.004, p ≤ .0083). Conclusions Schizophrenia patients with MetS showed significant cognitive impairments in three key cognitive domains. Aggressive medical treatment of the constituent components of MetS may provide the potential for important beneficial effects on patients' cognitive functioning.

Background Primary negative symptoms of schizophrenia contribute heavily to functional disability. Treatment of these symptoms continues to be a major unmet need, even when positive symptoms are controlled. Recent factor analyses of negative symptoms using the PANSS and other symptom assessments in patients with schizophrenia have identified two factors of negative symptoms: expressive and experiential deficits. These two factors most likely have very different clinical, neurocognitive and neurobiological correlates. This study examines the clinical and cognitive correlates associated with expressive and experiential deficits in a large cohort of patients with psychosis before and after computerized cognitive remediation. Methods This is a secondary data analysis of subjects enrolled in a cognitive remediation program for 12 weeks. One hundred fifty-one subjects age 18 - 55 with a DSM IV-TR diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder were enrolled. Assessments of demographic, psychopathology (PANSS), cognition (MCBB), and daily living skills (UPSA-Brief) were conducted at baseline and endpoint. Exploratory (EFA) and confirmatory (CFA) factor analyses of PANSS items as well as Pearson’s correlations between factors, demographics, MCCB, and UPSA-Brief scores were examined at baseline and endpoint. Results EFA baseline PANSS data resulted in the five-factor model of the PANSS with seven items attributed to the Negative Symptom Factor (NSF; N1, blunted affect; N2, emotional withdrawal; N3, poor rapport; N4, passive social withdrawal; N6, lack of spontaneity and flow of conversation; G7, motor retardation; and G16, active social avoidance). CFA of the NSF revealed a two-factor model consisting of an Expressive Deficit (N1, N3, N6, G7), and an Experiential Deficit (N2, N4, and G16). Difference tests comparing the one-factor and two-factor models found that the two-factor model exhibited significantly better fit than the one-factor model (χ2 = 67.117, df = 1, p ≤ 0.001; CFI = 0.92; Tucker–Lewis index TLI = 0.91; root mean square error of approximation RMSEA = 0.040; and Goodness of Fit index GFI = 0.93). There were significant correlations between the Expressive Deficit factor score and cognition: TMT- A (r=-0.259, p=0.001), BACS Symbol coding (r=-0.287, p=0.001), Category Fluency (r=-0.342, p=0.001), Hopkins Verbal Learning Test – revised (HTLV-R) (r=-0.236, p=0.05), Letter Number Sequencing (r=-0.256, P=0.001), and NAB Mazes (r=-0.409, p=0.001). The Expressive Deficit factor was also significantly correlated with the neurocognitive domains of Processing Speed (r=-0.352, p=0.001) and Reasoning/Problem Solving (r=-0.338, p=0.001). There were no significant correlations between either factor and UPSA-Brief or the MCCB cognitive composite. There were no significant correlations for change from baseline to endpoint in negative symptoms. Discussion Our results support the negative symptom two-factor model of Expressive Deficit and Experiential Deficit domains. Only the Expressive Deficit factor was associated with baseline deficits in Working Memory, Processing Speed, Reasoning/Problem Solving and Verbal Learning. The association of the Expressive Deficit factor with significant cognitive impairments supports a more profound neurobiological dysfunction in contrast to the Experiential Deficit factor and may represent an important treatment challenge. The relevance of these findings for the treatment of negative symptoms in schizophrenia will be discussed.

A program evaluation examined a long-term cognitive skills inpatient program (STAIR) in reducing rehospitalization and rearrest rates in mental illness. Psychiatric and criminal histories were obtained. Psychological tests were administered. After discharge, monthly follow-up was obtained. One hundred forty-five patients completed the STAIR program and were followed for a range of six to 60 months after discharge. Thirty-one (21.4%) remained stable, 67 (46.2%) were rehospitalized, and 47 (32.4%) were rearrested and/or rehospitalized. Group membership was predicted by STAIR admission age and outpatient medication compliance. Significantly, fewer arrests, hospitalizations, and days institutionalized occurred post-STAIR. Medication compliance is the single most enduring factor associated with clinical stability and prevention of criminal behavior. Other factors’ impact may vary depending on the length of stay in the community. Long-term inpatient programs (e.g., STAIR) may be helpful to some of these patients.

Background: The Positive and Negative Syndrome Scale (PANSS) is widely used for patients with schizophrenia. This scale is reliable and valid. The PANSS was translated and validated in several languages. Objective: The aim of this study was to translate and validate the PANSS in the Arab population. Subjects and Methods: The PANSS was translated into formal Arabic language using the back-translation method. 101 Arab patients with schizophrenia and 98 Arabs with no diagnosis of any mental disorder were recruited. The Arabic version of the Mini International Neuropsychiatric Interview (MINI-6) was used as a diagnostic tool to confirm the diagnosis of schizophrenia or rule out any diagnosis for the healthy control group. Reliability of the scale was assessed by calculating internal consistency, interrater reliability and test-retest reliability. Construct validity was assessed using the Arabic version of the MINI-6. PANSS total scores were correlated with the Clinical Global Impression-Severity scale. Results: Our findings showed that the internal consistency was good (0.92). Scores on the PANSS of the patients were much higher than those of the healthy controls. The PANSS showed good interrater reliability and test-retest reliability (0.92 and 0.75, respectively). In comparison with the MINI-6, the PANSS showed good sensitivity and specificity, which implies good construct validity of this version. Conclusion: In conclusion, the Arabic version of the PANSS is a reliable and valid instrument for the assessment of patients with schizophrenia in the Arab population.

OBJECTIVE Primary negative symptoms are intrinsic to the pathology of schizophrenia and are associated with significant deficits in motivation, verbal and nonverbal communication, affect, and cognitive and social functioning. Overall, atypical antipsychotic medications have been found to be more efficacious than conventional antipsychotics in the treatment of negative symptoms, based on studies with acute patients. Results have been confounded by concomitant improvements in positive, depressive, and extrapyramidal symptoms. This 12-week, double-blind, controlled study aimed to examine the effects of the atypical antipsychotic olanzapine versus haloperidol on persistent, primary negative symptoms and neurocognitive functions in stable schizophrenic patients with the deficit syndrome and low levels of concomitant positive, depressive, and extrapyramidal symptoms. METHOD Thirty-five patients with DSM-IV-TR schizophrenia and predominant negative symptoms were randomly assigned in a 12-week double-blind study to either olanzapine (15-20 mg/day) or haloperidol (15-20 mg/day). Patients taking haloperidol received additional blinded benztropine. Inclusion criteria were Positive and Negative Syndrome Scale (PANSS) negative score of >or=20, PANSS positive score < 20, and fulfilling the criteria for the Schedule for the Deficit Syndrome. The PANSS, Clinical Global Impressions, Hamilton Rating Scale for Depression (HAM-D), Simpson-Angus Scale, and Abnormal Involuntary Movement Scale were assessed at regular subsequent intervals. A neuropsychological battery examining declarative verbal learning memory, attention and processing speed, executive functioning, and simple motor functioning domains of cognition was assessed at baseline and endpoint. The study ran from September 1998 through May 2005. RESULTS CLINICAL RESULTS There was a statistically significant difference for PANSS negative symptoms (F = 5.44, df = 1,15; p

Background: The objective of this study was to examine the cross-cultural differences of the PANSS across six geo-cultural regions. The specific aims are (1) to examine measurement properties of the PANSS; and (2) to examine how each of the 30 items function across geo-cultural regions. Methods: Data was obtained for 1,169 raters from 6 different regions: Eastern Asia (n = 202), India (n = 185), Northern Europe (n = 126), Russia and Ukraine (n = 197), Southern Europe (n = 162), United States (n = 297). A principle components analysis assessed unidimensionality of the subscales. Rasch rating scale analysis examined cross-cultural differences among each item of the PANSS. Results: Lower item values reflects items in which raters often showed less variation in the scores; higher item values reflects items with more variation in the scores. Positive Subscale: Most regions found item P5 (Excitement) to be the most difficult item to score. Items varied in severity from −0.93 [item P6. Suspiciousness/persecution (USA) to 0.69 item P4. Excitement (Eastern Asia)]. Item P3 (Hallucinatory Behavior) was the easiest item to score for all geographical regions. Negative Subscale: The most difficult item to score for all regions is N7 (Stereotyped Thinking) with India showing the most difficulty Δ = 0.69, and Northern Europe and the United States showing the least difficulty Δ = 0.21, each. The second most difficult item for raters to score was N1 (Blunted Affect) for most countries including Southern Europe (Δ = 0.30), Eastern Asia (Δ = 0.28), Russia and Ukraine (Δ = 0.22) and India (Δ = 0.10). General Psychopathology: The most difficult item for raters to score for all regions is G4 (Tension) with difficulty levels ranging from Δ = 1.38 (India) to Δ = 0.72. Conclusions: There were significant differences in response to a number of items on the PANSS, possibly caused by a lack of equivalence between the original and translated versions, cultural differences among interpretation of items or scoring parameters. Knowing which items are problematic for various cultures can help guide PANSS training and make training specialized for specific geographical regions.

Background Nonparametric item response theory (IRT) was used to examine (a) the performance of the 30 Positive and Negative Syndrome Scale (PANSS) items and their options ((levels of severity), (b) the effectiveness of various subscales to discriminate among differences in symptom severity, and (c) the development of an abbreviated PANSS (Mini-PANSS) based on IRT and a method to link scores to the original PANSS. Methods Baseline PANSS scores from 7,187 patients with Schizophrenia or Schizoaffective disorder who were enrolled between 1995 and 2005 in psychopharmacology trials were obtained. Option characteristic curves (OCCs) and Item Characteristic Curves (ICCs) were constructed to examine the probability of rating each of seven options within each of 30 PANSS items as a function of subscale severity, and summed-score linking was applied to items selected for the Mini-PANSS. Results The majority of items forming the Positive and Negative subscales (i.e. 19 items) performed very well and discriminate better along symptom severity compared to the General Psychopathology subscale. Six of the seven Positive Symptom items, six of the seven Negative Symptom items, and seven out of the 16 General Psychopathology items were retained for inclusion in the Mini-PANSS. Summed score linking and linear interpolation was able to produce a translation table for comparing total subscale scores of the Mini-PANSS to total subscale scores on the original PANSS. Results show scores on the subscales of the Mini-PANSS can be linked to scores on the original PANSS subscales, with very little bias. Conclusions The study demonstrated the utility of non-parametric IRT in examining the item properties of the PANSS and to allow selection of items for an abbreviated PANSS scale. The comparisons between the 30-item PANSS and the Mini-PANSS revealed that the shorter version is comparable to the 30-item PANSS, but when applying IRT, the Mini-PANSS is also a good indicator of illness severity.

Background Galantamine, a reversible cholinesterase inhibitor with effects on nicotinic receptors, has shown mixed effects on cognitive impairments in patients with schizophrenia. Given these mixed results we examined whether galantamine compared to adjunctive placebo may improve cognitive functions in patients treated concomitantly with a long acting atypical antipsychotic. Method The parent study was a 52-week double-blind, randomized study of treatment with long-acting injectable risperidone 25 mg or 50 mg every two weeks. Adjunctive galantamine or placebo treatment was administered from Month 6 to 12. Outcome measures were neurocognitive, psychopathology, social and quality of life functions. Patients were randomized to blinded galantamine up to 24 mg/day or matching placebo tablets. All patients were maintained on their randomized long-acting injectable risperidone regimen for the duration of the trial. Results 32 patients were included in the intent-to-treat analysis. No statistically significant differences were found for Attention Vigilance, Declarative Memory, Processing Speed, Reasoning/Problem Solving, Working Memory domains and the Neurocognitive Composite Score. Group specific analysis showed a statistically significant group interaction ( p = 0.043) with the Social Cognition domain showing in the galantamine group significantly lower scores at endpoint than placebo patients. The PANSS general psychopathology subscale showed significantly higher scores in the galantamine group at endpoint ( p = 0.05). ANCOVA model for within treatment group comparisons showed a significant increase of 7.3 points for the total PANSS score for the galantamine group. Conclusion Galantamine showed no ameliorative effects on cognitive measures in this 6 month, double-blind study of patients with schizophrenia treated with an assured and stable antipsychotic medication delivery system. Galantamine may not be an appropriate augmentation agent for cognitive impairments in patients with schizophrenia at the dose used.

A key problem in schizophrenia research is how to assess the effects of treatment interventions given the spectrum of schizophrenia symptoms and patients' functioning. Measuring symptoms is complex, because these symptoms cover a wide variety of psychopathologic domains. The commonly recognized domains are the positive, negative, cognitive, excitement, and depression domains. This article critically reviews some of the available assessment tools of these domains together with other associated syndromes. The instruments discussed cover the broad range of psychopathology found in patients who have schizophrenia.

Objectives Developing empirically sound measures for social cognition is a key step in improving the factors that contribute to deficits in social functioning in schizophrenia. Investigating the psychometric properties and acceptability of social cognitive instruments may contribute to identification of a reliable and valid instrument for schizophrenia patients. Aims To investigate the psychometric properties and acceptability of a dynamic social cognition scale (DSCB) compared to three common social cognition instruments in schizophrenia. Methods 41 patients with schizophrenia were evaluated to assess acceptability, internal consistency and validity of five social cognition measures: DSCB, Emotion Recognition-40 (ER-40), Facial Emotion Identification Task (FEIT), Tone Matching Task and MSCEIT. Multiple linear regressions were conducted to identify variables which perform well as social cognition determinants. Results The DSCB and FEIT showed good acceptability, evidenced by shorter administration time, completion and patient preference for the DSCB. Good levels of internal consistency were found for the DSCB (α = 0.851), ER-40 (α = 0.803), and FEIT (α = 0.782). Confirmatory Factor Analysis indicated sufficient to good model fit. The DSCB and the ER-40 demonstrated a good model fit. The correlations for the DSCB were significant for the ER-40 ( r = 0.512) and FEIT ( r = 0.500). Conclusions Findings suggest that DSCB is the preferred instrument to evaluate social cognition, due to its dynamic nature and short administration time. Further research is needed to develop and improve these measurements. Additionally, the DSCB, FEIT and ER-40 show adequate to good reliability and validity.

Introduction Prognostic models discriminate between groups of individuals likely to experience better or worse outcomes and to predict response to treatment. Objectives The premise of the analysis was the assumption that baseline PANSS measurements could be a prognostic factor to inform decisions on the expected response (completion or early-termination) to treatment during participation in a clinical trial. Aims To examine early patterns/profiles based on PANSS and response to treatment (Study-Completer (SC), Early-Termination (ET)). Methods Receiver Operating Curves (ROC) was conducted on 809 subjects with SC versus ET. Factor structure assessed whether psychopathology constructs are comparable across SC and ET. Results Positive-Symptoms: P5.Grandiosity, P7.Hostility and P4.Excitement are not as good as others in predicting ET. 91.1% ET would have scores of 5, 6 or 7 on P1.Delusions. Negative-Symptoms: N5. Difficulty in Abstract Thinking and N6.Lack of Spontaneity and Flow of Conversation are not as good in predicting ET. 67.9% ET may have scores of 5, 6 or 7 on N1.Blunted Affect. General-Psychopathology: G3.Guilt Feelings, G6.Depression, G7.Motor Retardation, and G10.Disorientation are not as good in predicting ET. 73.2% ET have scores of 5, 6 or 7 on G9.Unusual Thought Content. Positive Factor accounted for the most variance 15.885%, then Negative factor=14.592%, then Hostile-Excitement=11.973% for SC. For ET, Negative Factor=13.713% variance, cognitive factor=12.451%, Excitement Factor=10.396%. Conclusions These findings represent patterns of early detection of response in clinical trials, and have led to the development of sophisticated algorithms that may allow investigators to identify ET and SC, which is important in trial success.

Background Patients with schizophrenia are known to have higher rates of mortality and morbidity when compared to the general population. Suicidality is a major contributor to increased mortality. The International Suicide Prevention Trial (InterSePT) Scale for Suicidal Thinking (ISST) is a validated tool to assess current suicidal ideation in patients with schizophrenia. The aims of the study were to culturally adapt the Arabic translation of ISST and to examine the psychometric characteristics of the Arabic version of the ISST among patients with schizophrenia in Qatar. Methods ISST was translated and adapted into formal Arabic using the back translation method. Patients diagnosed with schizophrenia were randomly recruited from the department of Psychiatry, Rumailah Hospital, Doha, Qatar. Healthy controls were randomly recruited from two primary health care centers in Doha, Qatar. The Arabic version of Module B for suicidality in Mini International Neuropsychiatric Interview was used as the gold standard to which the Arabic ISST was compared. Results The study sample (n = 199) was composed of 100 patients diagnosed with schizophrenia (age 35.30 ± 10.04 years; M/F is 2/1) and 99 controls (age 33.98 ± 8.33 years; M/F is 2/3). The mean score on the ISST was 3.03 ± 4.75 vs. 0.47 ± 1.44 for the schizophrenia and control groups, respectively. Inter-rater reliability coefficient was 0.95, p > 0.001. The overall Cronbach’s alpha was 0.92. Principal Component Analysis produced 3 factors explaining a total of 73.8% of variance. Conclusions This is the first study in the Arab countries to validate the Arabic version of the ISST. The psychometric properties indicate that the Arabic ISST is a valid tool to assess the severity of suicidal ideation in Arabic patients with schizophrenia.