Effects of Long-acting Injectable 3-Monthly Paliperidone Palmitate on the Clinical and Social Performance of Patients with Schizophrenia.

Objective: To investigate the effects of long-acting injectable 3-monthly paliperidone palmitate on the clinical and social functioning of patients with schizophrenia. Methods: This study enrolled patients with schizophrenia receiving long-acting injectable 1-monthly paliperidone palmitate for at least 4 months and who subsequently received 3-monthly paliperidone palmitate. Accordingly, 418 patients were followed up for 24 weeks. Their clinical symptoms and social functioning were measured using the Clinical Global Impression-Severity of Illness and Personal and Social Performance scales. Results: The Personal and Social Performance total score was significantly higher after 3-monthly paliperidone palmitate treatment than at baseline (baseline vs. week 24: 54.3 ± 18.0 vs. 61.0 ± 14.5 [mean ± standard deviation]; p < 0.001; Wilcoxon signed-rank test); the proportion of patients in the mildly ill group (scores 71-100) also increased significantly (baseline vs. week 24: 16.5% vs. 20.6%; p < 0.001; McNemar-Bowker test). The mean Clinical Global Impression-Severity of Illness score decreased significantly (baseline vs. week 24: 3.7 ± 1.0 vs. 3.4 ± 0.9; p < 0.001; Wilcoxon signed-rank test), as did the proportion of patients in the severely ill group (baseline vs. week 24: 4.1% vs. 2.1%; p < 0.001; McNemar-Bowker test). Conclusion: Continuous 3-monthly paliperidone palmitate treatment significantly enhances the personal and social performance of patients with schizophrenia and reduces the proportion of those with severe illness. These findings suggest that long-acting injectable antipsychotic administration at intervals longer than 1 month might improve the social functioning of and promote return to activities of daily living in patients with schizophrenia.

Psychosocial functioning as a personal resource promoting a milder course of schizophrenia.

Schizophrenia has been shown repeatedly to be associated with a low level of psychosocial functioning. It is assumable that psychosocial functioning is related not only to current, but also to future symptom severity. To test this assumption, a follow-up study with two measurement time points with an interval of 18 months was conducted. In total, 154 inpatients from five psychiatric hospitals with a diagnosis of a schizophrenic disorder took part at both visits. Psychosocial functioning was measured with the Personal and Social Performance Scale (PSP scale) at baseline, and schizophrenic symptoms were assessed with the Positive and Negative Syndrome Scale (PANSS) at baseline and at follow-up. Two PSP subscales, i.e. socially useful activities and control over disturbing and aggressive behavior, turned out to be significant predictors of symptom severity 18 months later. The findings reveal that personal resources in the occupational domain and in adequate interpersonal behavior can have a positive impact on the long-term course of schizophrenia.

Assessment of the Minimum Clinically Important Difference in Symptoms and Functions of Patients With Acute Schizophrenia: A Post hoc Analysis of an Open-Label, Single-Arm Multicenter Study.

The purpose of this study was to evaluate the application of the minimum clinically important difference (MCID) concept to clinical results in Chinese patients with acutely exacerbated schizophrenia. The original study was an 8-week, open-label, single-arm, multicenter study of flexible doses of paliperidone-extended release (pali-ER) in Chinese patients with acutely exacerbated schizophrenia. This is a post hoc analysis to determine the MCID value of PANSS, PSP and evaluate the responsiveness of each outcome measurements in the acute phase of schizophrenia. The responsiveness of the four measurements (PANSS, PANSS reduction rate, PSP, CGI-S) was analyzed. Four hundred ninety nine patients completed the 8-week follow-up and were finally used for this post hoc analysis. The MCID calculated by different approaches varied from 14.02 to 31.50 for PANSS, 15.14 to 42.79% for PANSS reduction rate, and 7.62 to 13.13% for PSP. In addition, the improvement of the CGI-S owned the highest responsiveness of the four outcome measurements. The threshold value of MCID for schizophrenia patients was determined by choice of the assessment method to an extent. In addition, the CGI-S score appeared to be the most valid and responsive measure of effectiveness for the acute phase of schizophrenia when take the treatment satisfaction of patients as anchor.

A Random Forest Model for Predicting Social Functional Improvement in Chinese Patients with Schizophrenia After 3 Months of Atypical Antipsychotic Monopharmacy: A Cohort Study.

PURPOSE: Impaired social functions contribute to the burden of schizophrenia patients and their families, but predictive tools of social functioning prognosis and specific factors are undefined in Chinese clinical practice. This article explores a machine learning tool to identify whether patients will achieve significant social functional improvement after 3 months of atypical antipsychotic monopharmacy and finds the defined risk factors using a multicenter clinical study. PATIENTS AND METHODS: A multicenter study on atypical antipsychotic (AAP) treatment in Chinese patients with schizophrenia (SALT-C) was conducted from July 2011 to August 2018. Data from 550 patients with AAP monopharmacy from their baseline to their 3-month follow-up were used to establish machine learning tools after screening. The positive outcome was an increase in the Personal and Social Performance (PSP) scale score by ≥10 points. The predictors were a range of investigator-rated assessments on symptoms, functioning, the safety of AAPs and illness history. The Least Absolute Shrinkage and Selection Operator (LASSO) was used for the feature screening and ranking of the predicted variables. The random forest algorithm and five-fold cross-validation for optimizing the model were selected to ensure the generalizability and precision. RESULTS: There were 137 patients (mean [SD] age, 41.1 [16.8] years; 77 [58.8%] female) who had a good social functional prognosis. A lower PSP score, taking a mood stabilizer, a high total Positive and Negative Symptom Scale (PANSS) and PANSS general subscale score, unemployment, a hepatic injury with medication, comorbid cardiovascular disease and being male predicted poor PSP outcomes. The generalizability of the PSP predictive tool was estimated with the precision-recall curve (accuracy of 79.5%, negative predictive value of 92.6% and positive predictive value of 57.1%) and receiver operating characteristic curve (ROC) (specificity of 81.8% and sensitivity of 78.7%). CONCLUSION: The machine learning tool established using our current real-world data could assist in predicting PSP outcome by several clinical factors.

Consistency checks to improve measurement with the Personal and Social Performance Scale (PSP).

International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Personal and Social Performance Scale (PSP). One hundred and forty seven flags were identified, 16 flag errors in deriving the PSP decile (i.e., total) score from the four individual domain scores, 74 flag inconsistencies between domain scores relative to Positive and Negative Symptom Scale (PANSS) item ratings and 57 flag inconsistencies between PSP decile score and PANSS items ratings. The flags were applied to assessments from randomized clinical trial data of antipsychotics in schizophrenia from almost 18,000 ratings. Twenty-two flags were raised in at least 5 of 1000 ratings. Nearly 20% of the PSP ratings had at least one inconsistency flag raised. Application of flags to clinical ratings may improve the reliability of ratings and validity of trials.

Assessing the efficacy and feasibility of providing metacognitive training for patients with schizophrenia by mental health nurses: A randomized controlled trial.

AIM: To evaluate the efficacy of metacognitive group training in reducing psychotic symptoms and improving cognitive insight and functions in people with schizophrenia. DESIGN: Randomized controlled trial. It was carried out between July 2019 -February 2020. METHODS: Fifty-six patients with schizophrenia were enrolled and randomly assigned to either a control group (N = 29) or a metacognitive training group (N = 27). Blinded assessments were made at baseline, 1-week post-treatment and at follow-up 3 months after treatment. The primary outcome measure was psychotic symptoms based on the Psychotic Symptom Rating Scales (PSYRATS). Secondary outcomes were assessed by the Beck Cognitive Insight Scale (BCIS), the Personal and Social Performance (PSP) scale and the World Health Organization Disability Assessment Schedule (WHODAS). RESULTS: Completion at follow-up was high (92.86%). The intention-to-treat analyses demonstrated that patients in the metacognitive training group had significantly greater improvements of the Psychotic Symptom Rating Scales delusion score and total score and the Personal and Social Performance Scale, after 3 months, compared with the control group. The effect size was medium to large. The intention-to-treat analyses also demonstrated that patients in the metacognitive training group had significantly greater reductions of the Psychotic Symptom Rating Scales hallucination score and Beck Cognitive Insight Scale self-certainty score post-treatment, compared with the control group. The effect size was medium to large. CONCLUSION: The metacognitive training administered by psychiatric and mental health nurses was effective in ameliorating delusions and social functioning over time and it immediately reduced hallucinations post-treatment. IMPACT: Metacognitive training for treating psychosis in patients with schizophrenia is efficacious and administration is clinically feasible in the Portuguese context. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov ID NCT03891186.

Raloxifene augmentation in men and women with a schizophrenia spectrum disorder: A study protocol.

Although acute psychotic symptoms are often reduced by antipsychotic treatment, many patients with schizophrenia are impaired in daily functioning due to the persistence of negative and cognitive symptoms. Raloxifene, a Selective Estrogen Receptor Modulator (SERM) has been shown to be an effective adjunctive treatment in schizophrenia. Yet, there is a paucity in evidence for raloxifene efficacy in men and premenopausal women. We report the design of a study that aims to replicate earlier findings concerning the efficacy of raloxifene augmentation in reducing persisting symptoms and cognitive impairment in postmenopausal women, and to extend these findings to a male and peri/premenopausal population of patients with schizophrenia. The study is a multisite, placebo-controlled, double-blind, randomised clinical trial in approximately 110 adult men and women with schizophrenia. Participants are randomised 1:1 to adjunctive raloxifene 120 mg or placebo daily during 12 weeks. The treatment phase includes measurements at three time points (week 0, 6 and 12), followed by a follow-up period of two years. The primary outcome measure is change in symptom severity, as measured with the Positive and Negative Syndrome Scale (PANSS), and cognition, as measured with the Brief Assessment of Cognition in Schizophrenia (BACS). Secondary outcome measures include social functioning and quality of life. Genetic, hormonal and inflammatory biomarkers are measured to assess potential associations with treatment effects. If it becomes apparent that raloxifene reduces psychotic symptoms and/or improves cognition, social functioning and/or quality of life as compared to placebo, implementation of raloxifene in clinical psychiatric practice can be considered.

Abnormal Contingent Negative Variation Drifts During Facial Expression Judgment in Schizophrenia Patients.

Schizophrenia patients often show impaired facial expression recognition, which leads to difficulties in adaptation to daily life. However, it remains unclear whether the deficit is at the perceptual or higher cognitive level of facial emotion processing. Recent studies have shown that earlier face-evoked event-related potential (ERP) components such as N170 and P100 can effectively distinguish schizophrenia patients from healthy controls; however, findings for later waveforms are ambiguous. To clarify this point, in this study we compared electroencephalographic signals in schizophrenia patients and control subjects during a facial expression judgment task. We found that group effects of the occipital N170 and frontal lobe contingent negative variation (CNV) were both significant. The effect sizes (ESs) of N170 and CNV amplitudes were generally medium or small, whereas that of CNV slope for an upright face was large (>0.8). Moreover, N170 amplitude and CNV slope but not CNV amplitude was correlated with Personal and Social Performance (PSP) Scale score. These results suggest that the slope of CNV drift during facial expression processing has a potential clinical value for schizophrenia.

Social and functional outcomes with two doses of aripiprazole lauroxil vs placebo in patients with schizophrenia: a post-hoc analysis of a 12-week phase 3 efficacy study.

To assess the effect of the long-acting antipsychotic aripiprazole lauroxil (AL) on social and functional outcomes compared with placebo in patients with acute schizophrenia, a post-hoc analysis was conducted. Patients with acute schizophrenia were enrolled in a 12-week, double-blind, placebo-controlled efficacy trial, and randomized 1:1:1 to receive AL 441 mg, AL 882 mg, or placebo every 4 weeks. Changes in social functioning using the 6- and 4-item Positive and Negative Syndrome Scale (PANSS) Prosocial subscales were evaluated. The Personal and Social Performance (PSP) total score evaluated patients' global improvement. Changes from baseline were analyzed using mixed-effect models repeat measurements. PANSS Prosocial subscale scores and PSP total score improved significantly with AL vs. placebo, without any dose-related difference in magnitude of response. Significant mean ± SE improvements in 6-item PANSS Prosocial scores from baseline to Day 85 were observed for both individual active treatment groups (e.g., AL 441 mg and AL 882 mg groups) vs. placebo. There were significant changes in PSP total score from baseline to Day 85 for both AL doses vs. placebo. This post-hoc analysis demonstrated a significant improvement in social functioning with AL vs. placebo, as assessed by the PANSS Prosocial subscale and PSP total score.

Aripiprazole Long-Acting Injection During First Episode Schizophrenia-An Exploratory Analysis.

Background: Long-acting injectable (LAI) aripiprazole was found to be efficacious in schizophrenia. In common clinical practice, the use of LAIs is often restricted to chronic patients with frequent relapses and poor adherence. Recently, some investigators advanced the idea of early LAI use also in young people with schizophrenia at their first psychotic episode (FEP). Objective: Our study aimed to assess the effect of LAI aripiprazole once monthly (AOM) in the treatment of FEP in patients aged 18-26 years. Methods: We included 50 patients with DSM-5 schizophrenia as assessed with SCID, and used the Clinical Global Impressions Scale-Severity of Illness (CGI-S) and the Positive and Negative Syndrome Scale (PANSS) to assess symptom severity and the World Health Organization Quality of Life (WHOQOL), the Short Form Health Survey (SF-36) and the Personal and Social Performance Scale (PSP) to assess quality of life (QoL) and global health perception at baseline and 3, 6, 9, and 12 months after the first AOM injection. Results: AOM was associated with a progressive improvement, compared to baseline, of both positive (p < 0.001) and negative (p < 0.001) symptoms and in general psychopathology (p < 0.001) and decrease in global severity (p < 0.001). We also observed progressive improvement in QoL and social and personal functioning. Treatment adherence was 78% at study endpoint. Our results support that AOM may improve psychotic symptoms, QoL and social functioning in young FEP patients. Further studies should compare AOM to its oral formulation in the treatment of young patients with schizophrenia at the outset of their illness.

Estimate dynamic changes of dysfunction and lifelong spent for psychiatric care needs in patients with schizophrenia.

BACKGROUND: Disturbance of functionality is one of the core features of schizophrenia, and has deleterious effects on a patient's employment, increased healthcare costs, and a large societal burden. Thus, if a patient's disability status could be predicted, and interventions needed identified in advance, poor outcomes could be prevented. To achieve this aim, we developed a method by which to assess dynamic changes of dysfunction and estimate the lifetime duration of disability in patients with schizophrenia, as a proxy for assessing their specialized healthcare needs. METHODS: The proposed method was developed based on a nationwide database and a cross-sectional survey. The primary analysis investigated the dynamic change in the proportion of patients with manifested disability over time, while the secondary analysis estimated the lifetime duration of disability, obtained as the proportion of patients with manifested disability multiplied by the survival probability throughout the life of patients. RESULTS: The average lifetime duration of manifested disability of global functioning was estimated to be 20.9 years, which represents approximately 73% of the whole lifetime of patients. The duration of disability in socially-useful activities was estimated to be 15.6 years, while that in personal and social relationships was 17.5 years. The female patients had a longer duration of manifested disability (22.9 years) than the male patients (19.5 years). CONCLUSIONS: The developed method of analysis indicated that the longest lifetime durations of manifest disability were observed in the areas of socially-useful activities and personal and social relationships, and the proportions of patients with these disabilities rapidly increased at 200 months after diagnosis.

Paliperidone palmitate once-monthly maintains improvement in functioning domains of the Personal and Social Performance scale compared with placebo in subjects with schizoaffective disorder.

OBJECTIVE: Evaluate the effect of paliperidone palmitate once-monthly (PP1M) injectable on the specific functioning domains of the Personal and Social Performance (PSP) scale in patients with schizoaffective disorder (SCA) participating in a long-term study. METHODS: This study (NCT01193153) included both in- and outpatient subjects with SCA experiencing an acute exacerbation of psychotic and mood symptoms. Subjects were treated with PP1M either as monotherapy or in combination with antidepressants or mood stabilizers during a 25-week open-label (OL) phase. Stabilized subjects were randomly assigned 1:1 (PP1M or placebo) into a 15-month double-blind (DB) relapse-prevention period. Functioning of the randomized subjects during OL and DB phases was evaluated using the PSP scale (four domains: socially useful activities, personal/social relationships, self-care, and disturbing/aggressive behaviors). Three statistical approaches were utilized to analyze PSP scores to assess robustness and consistency of findings. No adjustments were made for multiplicity. RESULTS: 334 of 667 enrolled subjects were stabilized with PP1M, randomly assigned to PP1M (n=164) or placebo (n=170) in the DB phase, and included in this analysis. Improvements in all PSP domain scores were observed during the OL phase and were maintained during the DB phase with PP1M, but decreased with placebo. Differences compared to placebo were significant in all four PSP domains during the DB phase (P≤0.008). CONCLUSION: The analysis in this study showed that PP1M improves functioning, as measured by the four PSP domain scores, in symptomatic subjects with SCA. Functioning was maintained compared with placebo.

Applicability of the Chinese version of the Personal and Social Performance scale in patients with severe mental disorders.

INTRODUCTION: This study was designed to determine the reliability and validity of the Chinese version of the Personal and Social Performance scale (PSP-CHN) and assess the applicability of using the PSP-CHN in patients with severe mental disorders. METHODS: A total of 285 outpatients with severe mental disorders, 220 with schizophrenia and 65 with major depressive disorder, were enrolled into the study. Both diagnoses were made using the DSM-IV. All the patients were assessed with the PSP-CHN, the GAF, and the CGI-S. In addition, the PANSS and the MADRS were used to assess the patients with schizophrenia and major depressive disorder, respectively. RESULTS: The PSP-CHN showed good internal consistency (Cronbach α = 0.839, n = 285), high interrater reliability for total scores (intraclass correlation coefficient, ICC = 0.865, n = 48), and good test-retest reliability (ICC = 0.892, n = 130). The PSP-CHN total score showed a statistically significant positive correlation with the GAF score (r = 0.927, P < .01, n = 285), as well as a significant negative correlation with the CGI-S total score (r = -0.793, P < .01, n = 285), the PANSS total score (r = -0.694, P < .01, n = 220), and the MADRS total score (r = -0.721, P < .01, n = 65). DISCUSSION: We were able to demonstrate that the PSP-CHN is a reliable and valid measurement tool to assess the personal and social functioning in patients with severe mental disorders.

Minimal detectable change of the Personal and Social Performance scale in individuals with schizophrenia.

The minimal detectable change (MDC) of the Personal and Social Performance scale (PSP) has not yet been investigated, limiting its utility in data interpretation. The purpose of this study was to determine the MDCs of the PSP administered by the same rater or different raters in individuals with schizophrenia. Participants with schizophrenia were recruited from two psychiatric community rehabilitation centers to complete the PSP assessments twice, 2 weeks apart, by the same rater or 2 different raters. MDC values were calculated from the coefficients of intra- and inter-rater reliability (i.e., intraclass correlation coefficients). Forty patients (mean age 36.9 years, SD 9.7) from one center participated in the intra-rater reliability study. Another 40 patients (mean age 44.3 years, SD 11.1) from the other center participated in the inter-rater study. The MDCs (MDC%) of the PSP were 10.7 (17.1%) for the same rater and 16.2 (24.1%) for different raters. The MDCs of the PSP appeared appropriate for clinical trials aiming to determine whether a real change in social functioning has occurred in people with schizophrenia.

Longitudinal relationship between Personal and Social Performance (PSP) and anxiety symptoms in schizophrenia.

BACKGROUND: We aimed to examine the longitudinal relationship between the personal and social functioning and anxiety symptoms in patients with schizophrenia. For this purpose, we confirmed the validity of the anxiety subscale of the Symptom-Checklist-90-Revised (SCL-90-R) and then applied the latent growth modeling method for longitudinal causal relationships. METHODS: Five hundred and seventy-eight patients diagnosed with schizophrenia were evaluated and 369 patients were included in the study at baseline. After conducting Rasch model analyses for the validation of the anxiety subscale in the SCL-90-R, we applied latent growth model to determine the causal relationship between the PSP and the anxiety symptoms. RESULTS: The validity of the anxiety subscale of the SCL-90-R was confirmed based on the Rasch rating model, where the criteria for Infit, Outfit, item difficulty, and point-measure correlations were satisfied. The results from the latent growth model showed that the intercept and slope (rate of change) of the PSP negatively predicted the slope of anxiety symptoms along the longitudinal trajectory. Together with previous studies examining the predictive role of anxiety symptoms on quality of life, our longitudinal findings lend evidence for bidirectional effects between quality of life and anxiety symptoms. The transactional nature of the relationship between anxiety symptoms and quality of life warrant further investigation using a longitudinal cross-lagged design. CONCLUSION: The anxiety subscale of the SCL-90-R may be utilized by clinicians and researcher to make inferences about quality of life in addition to assessing anxiety symptoms in patients with schizophrenia.

An open-label, flexible-dose study of paliperidone extended-release in Chinese patients with first-onset psychosis.

BACKGROUND: Antipsychotic medications facilitate the improvement of psychotic symptoms in patients with first-episode psychosis. Paliperidone extended-release (pali-ER), an atypical antipsychotic, was assessed for efficacy and safety in Chinese patients with first-episode psychosis. METHODS: In this 8-week, open-label, single-arm, multicenter study, patients with first-episode psychosis (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) and a Positive and Negative Syndrome Scale (PANSS) total score ≥70 were treated with flexible-dose pali-ER tablets (3-12 mg/day). The primary efficacy endpoint was the percentage of patients with an increase of ≥8 points in Personal and Social Performance (PSP) score from baseline to day 56 (8 weeks). Secondary endpoints included reduction in PANSS total score, improvement in Clinical Global Impression-Severity score, PSP score, Subjective Well-being under Neuroleptics Scale score, and relationship between duration of untreated psychosis and PANSS or PSP. Incidences of treatment-emergent adverse events were used to evaluate safety. RESULTS: Overall, 283 of 294 patients (96%) achieved a ≥8-point increase in PSP (primary endpoint, analysis set). For the secondary efficacy endpoints, 284/306 patients (93%) had a ≥30% reduction in PANSS total score; 266/306 patients (87%) achieved a ≤3 Clinical Global Impression-Severity scale score, and 218/294 patients (74%) had a PSP score ≥71. The Subjective Well-being under Neuroleptics Scale score was improved from a baseline mean of 72.7 to 94.7 at endpoint. There was a negative correlation between duration of untreated psychosis and posttreatment PSP score and a positive correlation with posttreatment PANSS total score. The most common treatment-emergent adverse events were extrapyramidal symptoms (12%), and agitation, somnolence, and xerostomia (4% each). CONCLUSION: An 8-week, flexible-dose (3-12 mg/day) treatment with pali-ER resulted in significant improvements in psychotic symptoms and social functioning in Chinese patients with first-episode psychosis and was generally tolerable.

The Specific Level of Functioning Scale: construct validity, internal consistency and factor structure in a large Italian sample of people with schizophrenia living in the community.

BACKGROUND: The study aimed to assess the construct validity, internal consistency and factor structure of the Specific Levels of Functioning Scale (SLOF), a multidimensional instrument assessing real life functioning. METHODS: The study was carried out in 895 Italian people with schizophrenia, all living in the community and attending the outpatient units of 26 university psychiatric clinics and/or community mental health departments. The construct validity of the SLOF was analyzed by means of the multitrait-multimethod approach, using the Personal and Social Performance (PSP) Scale as the gold standard. The factor structure of the SLOF was examined using both an exploratory principal component analysis and a confirmatory factor analysis. RESULTS: The six factors identified using exploratory principal component analysis explained 57.1% of the item variance. The examination of the multitrait-multimethod matrix revealed that the SLOF factors had high correlations with PSP factors measuring the same constructs and low correlations with PSP factors measuring different constructs. The confirmatory factor analysis (CFA) corroborated the 6-factor structure reported in the original validation study. Loadings were all significant and ranged from a minimum of 0.299 to a maximum of 0.803. The CFA model was adequately powered and had satisfactory goodness of fit indices (comparative fit index=0.927, Tucker-Lewis index=0.920 and root mean square error of approximation=0.047, 95% CI 0.045-0.049). CONCLUSION: The present study confirms, in a large sample of Italian people with schizophrenia living in the community, that the SLOF is a reliable and valid instrument for the assessment of social functioning. It has good construct validity and internal consistency, and a well-defined factor structure.

Bipolar II disorder in patients with a current diagnosis of recurrent depression.

OBJECTIVES: The prevalence of bipolar II disorder (BD-II) in Russia has never been studied. Therefore, we sought to identify patients meeting diagnostic criteria for BD-II among patients with a current diagnosis of recurrent depressive disorder (RDD) through the use of the Russian versions of the Hypomania Checklist (HCL-32) and Bipolarity Index scales for differentiating between BD-II and RDD. METHODS: In a non-interventional diagnostic study, we selected 409 patients aged between 18 and 65 years from two medical settings with (i) a current diagnosis of RDD, (ii) an illness duration of at least three years, and (iii) at least two affective episodes. The diagnosis was based on clinical assessment and confirmed by the Russian version of the Mini International Neuropsychiatric Interview. All patients were assessed by the HCL-32, the Bipolarity Index, and the Personal and Social Performance Scale. RESULTS: Among patients with a current diagnosis of RDD, 40.8% had a diagnosis of bipolar disorder (bipolar I disorder: 4.9%; BD-II: 35.9%). The average time lag from onset to a correct diagnosis of BD-II was 15 years and patients were treated only with antidepressants. The sensitivity of the Russian version of the HCL-32 at the optimal cutoff point (≥14.0) was 83.7%, and its specificity was 71.9%. The Bipolarity Index showed significant differences between the total scores of the patients with BD-II and RDD (31.8 versus 20.2; p < 0.0001). The optimal threshold was ≥22.0 (sensitivity 73.5%; specificity 72.3%). CONCLUSIONS: In Russia, diagnostic errors are an important cause of the non-detection of bipolar disorder, particularly BD-II. The Russian version of the HCL-32 and the Bipolarity Index, as additional tools, could be useful for bipolarity screening.

Treatment of acute schizophrenia with paliperidone ER: predictors for treatment response and benzodiazepine use.

The Paliperidone ER Treatment in Acute Intervention (PERTAIN) study was designed to explore treatment response, tolerability, and safety of flexible doses of paliperidone ER in patients with schizophrenia admitted for an acute exacerbation. This paper addresses a secondary analysis of PERTAIN data designed to explore predictors for treatment response, flexible dosing, and concomitant benzodiazepine use. This prospective, multicenter, phase 3b, open-label, single-arm, 6-week study used flexible doses of paliperidone ER (3 to 12mg once daily) to treat patients hospitalized for an acute exacerbation of schizophrenia, reflecting more closely daily clinical practice. Predictive models were evaluated for paliperidone ER flexible dosing, treatment response, and concomitant treatment with benzodiazepines as distinct independent variables. For the analysis of explanatory variables, a stepwise logistic regression was used, taking into account patient age, gender, body mass index, diagnosis and duration of schizophrenia, number of prior hospitalizations, psychotic symptoms (PANSS), disease severity (CGI-S), and patient functioning (PSP) at baseline. Early response (defined as response within 2weeks of treatment initiation) was also used as a predictor. Clinical response (defined as ≥30% decrease in PANSS total score and ≥1 point decrease in CGI-S from baseline to endpoint) was predicted by early clinical response (p<0.001) and there was a trend for the diagnosis of paranoid schizophrenia vs. other types of schizophrenia to predict clinical response (p=0.0525). High response (defined as ≥50% decrease in PANSS total score and ≥2 points decrease in CGI-S from baseline to endpoint) was predicted by early high response, higher baseline CGI-S, or female gender. More severely ill patients with a higher baseline CGI-S were twice likely to be treated concomitantly with a benzodiazepine.

Evaluation of Reliability and Validity of the Chinese Version of Personal and Social Performance Scale in Patients with Schizophrenia / 中国心理卫生杂志

Objective:To evaluate the reliability and validity of the Chinese version of the Personal and Social Performance scale (PSP-CHN) in patients with schizophrenia.Methods:Totally 165 out-patients and in-patients meeting the DSM-IV-TR criteria for schizophrenia were entered in the study.Ten of subjects was included the intra-rater reliability training.The Global Assessment of Functioning Scale (GAF) was regarded as the' gold standard' to investigate the validity of PSP-CHN,and the Positive and Negative Rating Scale was used to assess the severity of disease to explore the correlative validity,in the other 155 subjects.Five to seven days after the first PSP-CHN interview,the second PSP-CHN was evaluated by another investigator to assess the test-retest reliability among 66 subjects.Twenty-seven subjects with the score of Positive and Negative Syndrome Scale (PANSS) more than 60 were followed up for 8 weeks of standardized pharmacotherapy.By the end of 8 week of treatment,the PANSS and PSP-CHN were assessed again to explore the sensitivity of PSP-CHN.Results:The internal consistency (Cronbach α=0.84) and the inter-rater reliability (κ value=0.56,ICC=0.94 for PSP-CHN total score) were good.The test-retest reliability was high [intraclass correlation coefficient (ICC) of 0.95].The scale showed good construct validity with statistically significant correlations with the Global Assessment of Functioning Scale (GAF) (ICC of 0.95).The PSP-CHN score had a good negative correlation with the PANSS total score(r=-0.79,-0.57,-0.63 and -0.71,respectively,P<0.01).After 8 week treatment,PSP-CHN total score was increased with the improvement of PANSS,and the responder showed higher increasing of PSP-CHN total score (21.2) than those partial responder(10.2),significantly.Conclusion:The Chinese version of the PSP-CHN is a convenient and valid instrument to assess the personal and social functions of stabilized and acute patients with schizophrenia.