The aim of this analysis was to identify Young Mania Rating Scale (YMRS) meaningful benchmarks for clinicians (severity threshold, minimal clinically significant difference [MCSD]) using the Clinical Global Impressions Bipolar (CGI-BP) mania scale, to provide a clinical perspective to randomized clinical trials (RCTs) results. We used the cohort of patients with acute manic/mixed state of bipolar disorders (N = 3459) included in the European Mania in Bipolar Longitudinal Evaluation of Medication (EMBLEM) study. A receiver-operating characteristic analysis was performed on randomly selected patients to determine the YMRS optimal severity threshold with CGI-BP mania score ≥ "Markedly ill" defining severity. The MCSD (clinically meaningful change in score relative to one point difference in CGI-BP mania for outcome measures) of YMRS, was assessed with a linear regression on baseline data. At baseline, YMRS mean score was 26.4 (±9.9), CGI-BP mania mean score was 4.8 (±1.0) and 61.7% of patients had a score ≥ 5. The optimal YMRS severity threshold of 25 (positive predictive value [PPV] = 83.0%; negative predictive value [NPV] = 66.0%) was determined. In this cohort, a YMRS score of 20 (typical cutoff for RCTs inclusion criteria) corresponds to a PPV of 74.6% and to a NPV of 77.6%, meaning that the majority of patients included would be classified as severely ill. The YMRS minimal clinically significant difference was 6.6 points.

Olanzapine 5 mg/day was effective in treating negative symptoms in a group of schizophrenic with predominantly negative symptoms during the stabilization phase. Improvement in positive symptoms or extrapyramidal symptoms (EPS) was unlikely to explain this result while improvement in depression may have partially contributed.

BackgroundOlanzapine long-acting injection (LAI) for the treatment of schizophrenia was associated with a cluster of symptoms termed post-injection delirium/sedation syndrome (PDSS) in a small percentage (~2%) of patients during clinical trials. The objective of this analysis was to evaluate the rate and clinical characteristics of PDSS since olanzapine LAI entered commercial use.MethodsCases of PDSS were identified from all reported adverse events during worldwide commercial use of olanzapine LAI through to 1 March 2014. Data sources included two ongoing post-marketing safety studies as well as spontaneously reported adverse events from routine clinical practice over a 5-year period (1 March 2009 to 1 March 2014).ResultsA total of 338 PDSS events were identified. Of these, 91% occurred within 1 hour of injection, and 52% of these occurred within 15 minutes. None of the PDSS events in this analysis were fatal, and most resolved within 72 hours. The most common symptoms (occurring in >30% of cases) were sedation (61%), confusion (56%), dysarthria (54%), somnolence (46%), dizziness (45%) and disorientation (35%). Overall, PDSS occurred with approximately 0.07% of injections and in 0.46–1.03% of patients (reporting and incidence rates from spontaneous reports and post-marketing safety studies, respectively).ConclusionsThe PDSS events reported during routine clinical use of olanzapine LAI are generally similar in incidence and presentation to those reported in clinical trials. Caution should be applied when interpreting spontaneously reported rates of adverse events, however, due to potential under-reporting. Implemented risk-minimisation activities may contribute substantially to the identification and appropriate management of patients with PDSS in clinical practice.Electronic supplementary materialThe online version of this article (doi:10.1186/s12888-015-0450-9) contains supplementary material, which is available to authorized users.

Depression is the most common mental disorder general practitioners (GPs) encounter, with very high prevalence rates currently reported among populations of patients consulting in the primary care sector (10% to 25%) (2-4). However, attending physicians often fail to diagnose and treat patients suffering from depression (5), especially in the absence of

This analysis aimed to examine the association between remission and quality of life (QOL) in schizophrenia. In post-hoc analyses of the 3-year, prospective, observational Schizophrenia Outpatients Health Outcomes (SOHO) study, we compared the QOL of patients who achieved symptomatic and clinical remission with those who did not, and the factors associated. Symptomatic remission was defined as achieving a score of ≤ 3 on the Clinical Global ImpressionsSchizophrenia (CGI-SCH) scale, maintained for at least 6 months and without hospitalization. QOL was patient self-rated using the European-QOL. Of the 6516 patients analysed, 38% were in symptomatic remission 12 months post-baseline and 52% at 36 months. Functional remission remained fairly constant from 12 months to 36 months (22.4% at both time points). At all visits from 12 to 36 months, patient QOL and social functioning were significantly higher for patients in symptomatic remission. QOL was higher in patients in functional remission compared to those not in functional remission at all time points. Patients with maintained symptomatic remission over the 3-year follow-up had a much greater improvement in QOL than patients with no symptomatic remission or symptomatic remission for part of the period. Factors associated with a better QOL included symptomatic remission, paid employment, socially active, having a higher CGI-SCH cognitive score, good compliance, and a better baseline QOL. Achieving symptomatic remission in schizophrenia is associated with an increase in patient self-perceived QOL, even when adjusting for confounding factors.