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Objective: Evidence of larger drug effects in highly standardized studies (efficacy) compared to clinical routine (effectiveness) is discussed as efficacy-effectiveness gap. This study aimed to quantify effect size differences of RCTs and non-RCTs in the treatment of depression with venlafaxine and duloxetine and to identify effect modifying predictors., Methods: A comprehensive systematic review and meta-analysis was conducted, including all prospective trials, which evaluated the treatment effects of duloxetine or venlafaxine in patients with depression. The primary outcome was the pre-post effect size after acute therapy, which were compared between RCTs and non-RCTs. Moreover, an exploratory analysis of predictors in a mixed meta-regression model within an information-theoretic approach was performed., Results: 171 RCTs and 74 non-RCTs were included. The pre-post effect size differed significantly between RCTs and non-RCTs (-3.04 vs. -2.62, Δ = 0.41, p = 0.012, high heterogeneity). Study characteristics were very similar between RCTs and non-RCTs. Most important variables to predict effect sizes were 'depression severity', 'dose' and 'number of participants'., Conclusion: Despite differences in effect sizes between RCTs and non-RCTs, study design is not clearly an important predictor for the effect sizes. Our results question the common assumption that non-RCTs are generally better suited to describe a drug's effectiveness in clinical practice than RCTs. Future studies and their reporting should put more emphasis on the description of external validity, in order to allow better assessments of clinical relevance., (© 2021 The Authors. Acta Psychiatrica Scandinavica published by John Wiley & Sons Ltd.)

Objective: Our analysis aimed at comparing the placebo effect sizes from randomized controlled trials (RCTs) of two widely prescribed antidepressants, namely duloxetine and venlafaxine, and at analysing a potential influence of the investigated drugs on the placebo response., Method: We conducted a comprehensive systematic review and meta-analysis of placebo-controlled, double-blind RCTs, which examined the efficacy of duloxetine and venlafaxine in the acute treatment of major depressive disorder., Results: We included 71 studies (29 duloxetine trials and 43 venlafaxine trials; one study provided data for the duloxetine and the venlafaxine data set). The placebo effect sizes, defined as pre-postscore change divided by baseline standard deviation, differed significantly between venlafaxine and duloxetine studies (-2.51 vs. -2.09; test for subgroup differences P = 0.028; high heterogeneity). The analysis of effect modifiers and the metaregression analyses confirmed the drug, next to baseline depression severity and publication status, as the most influential independent predictor., Conclusion: Our analyses show a significant difference in the placebo response between venlafaxine and duloxetine trials and suggest that the investigated drug has an influence on the placebo response that is not related to baseline severity, changes over the years or other variables we included., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Objective: In the past, the comparability of empirical studies that examined the course and outcome of schizophrenia was limited by their use of different diagnostic systems. Focussing on the psychopathological long-term outcome, the present article aims to review follow-up studies that used modern operationalized diagnostic criteria for schizophrenia (DSM-III, DSM-III-R, DSM-IV and ICD-10)., Method: We searched MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, PsycINFO and PSYNDEX for relevant studies up to the year 2011. Twenty-one studies were included in the final analysis., Results: The long-term outcome of schizophrenia was heterogeneous and included full remissions as well as severe chronic states. Schizophrenia, however, showed a considerably more unfavourable outcome than other diagnostic groups such as schizoaffective or affective disorders. Psychopathological symptoms remained relatively stable in the course of illness. Several predictors for a poor outcome were identified, such as male gender or pronounced negative symptoms., Conclusion: Recent studies using modern diagnostic systems largely confirm the results of earlier studies. Current diagnostic criteria for schizophrenia identify a heterogeneous sample of patients. The influence of therapeutic interventions on long-term outcome remains unclear., (© 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.)

Objective: Evaluating the effects of different types of psychotropic polypharmacy on clinical outcomes and quality of life (QOL) in 374 patients with schizophrenia and schizoaffective disorder in routine care., Method: Psychotropic regimen, clinical outcomes, and QOL were assessed before discharge and after 6, 12, 18, and 24 months. Data were analyzed by mixed-effects regression models for longitudinal data controlling for selection bias by means of propensity scores., Results: At baseline 22% of participants received antipsychotic monotherapy (APM) (quetiapine, olanzapine, or risperidone), 20% more than one antipsychotic drug, 16% received antipsychotics combined with antidepressants, 16% antipsychotics plus benzodiazepines, 11.5% had antipsychotics and mood stabilizers, and 16% psychotropic drugs from three or more subclasses. Patients receiving APM had better clinical characteristics and QOL at baseline. Patients receiving i) antipsychotics plus benzodiazepines or ii) antipsychotics plus drugs from at least two additional psychotropic drug categories improved less than patients with APM., Conclusion: Combinations of antipsychotics with other psychotropic drugs seem to be effective in special indications. Nevertheless, combinations with benzodiazepines and with compounds from multiple drug classes should be critically reviewed. It is unclear whether poorer outcomes in patients with such treatment are its result or its cause., (© 2012 John Wiley & Sons A/S.)

Objective: To determine the short-term antidepressant efficacy and tolerability of duloxetine and venlafaxine vs. each other, placebo, selective serotonin reuptake inhibitors (SSRIs), and tri- and tetracyclic antidepressants (TCAs) in adults with major depression., Method: Meta-analysis of randomised controlled trials identified through bibliographical databases and other sources, including unpublished manufacturer reports., Results: Fifty-four studies including venlafaxine arms (n = 12,816), 14 including duloxetine arms (n = 4,528), and two direct comparisons (n = 836) were analysed. Twenty-three studies were previously unpublished. In the meta-analysis, both duloxetine and venlafaxine showed superior efficacy (higher remission and response rates) and inferior tolerability (higher discontinuation rates due to adverse events) to placebo. Venlafaxine had superior efficacy in response rates but inferior tolerability to SSRIs (OR = 1.20, 95% CI 1.07-1.35 and 1.38, 95% CI 1.15-1.66, respectively), and no differences in efficacy and tolerability to TCAs. Duloxetine did not show any advantages over other antidepressants and was less well tolerated than SSRIs and venlafaxine (OR = 1.53, 95% CI 1.10-2.13 and OR 1.79, 95% CI 1.16-2.78, respectively)., Conclusion: Rather than being a first-line option, venlafaxine appears to be a valid alternative in patients who do not tolerate or respond to SSRIs or TCAs. Duloxetine does not seem to be indicated as a first-line treatment., (© 2010 John Wiley & Sons A/S.)

Objective: Schizoaffective disorder is a common diagnosis in mental health services. The aim of the present article was to review treatment studies for schizoaffective disorder and draw conclusions for clinical decision making., Method: We searched MEDLINE and Cochrane Library for relevant clinical trials and review articles up to the year 2008., Results: Thirty-three studies using standardized diagnostic criteria, 14 of which were randomized controlled trials, could be identified. The comparability of studies is limited by the use of different diagnostic criteria. The studies reviewed do not permit consistent recommendations as to whether schizoaffective disorder should be treated primarily with antipsychotics, mood stabilizers or combinations of these drugs. The relevance of diverse subtypes of schizoaffective disorder for treatment recommendations is unclear., Conclusion: The pertinent empirical database is small and heterogeneous. The lack of conclusive recommendations is related to issues of nosological status, plurality of diagnostic criteria and validity of the concept of schizoaffective disorder.

Objective: To delineate methods and to describe patient appraisal as well as effect of outcome management in in-patient psychiatric care., Method: Two hundred and ninety-four adults with mental illness receiving in-patient treatment at a psychiatric hospital in rural Bavaria gave informed consent to participate in this cluster-randomised trial. Participants were asked to provide information on treatment outcome via weekly computerised standardised assessments. Patients and clinicians in the intervention group received continuous feedback of outcome., Results: Patients were willing and able to regularly provide outcome data and valued feedback. However, use of feedback in conversations between patient and clinician was rare. Outcome management failed to impact on patient-rated outcome during in-patient treatment., Conclusion: Outcome management is feasible in people receiving in-patient psychiatric care, but failed to show an overall short-term effect. Strategies need to be developed to improve active use of routinely collected treatment outcome data in mental health care.

Objective: To determine and estimate the efficacy of discharge planning interventions in mental health care from in-patient to out-patient treatment on improving patient outcome, ensuring community tenure, and saving costs., Method: A systematic review and meta-analysis identified studies through an electronic search on the basis of defined inclusion and exclusion criteria and extracted data., Results: Of eleven studies included, six were randomised controlled trials, three were controlled clinical trials, and two were cohort studies. The discharge planning strategies used varied widely, most were limited to preparation of discharge during in-patient treatment. Pooled risk ratios were 0.66 (95% CI = 0.51 to 0.84; P < 0.001) for hospital readmission rate, and 1.25 (1.07 to 1.47; P < 0.001) for adherence to out-patient treatment. Effect sizes (Hedge's g) were -0.25 (-0.45 to -0.05; P = 0.02) for mental health outcome, and 0.11(-0.05 to 0.28; NS) for quality of life., Conclusion: Discharge planning interventions are effective in reducing rehospitalisation and in improving adherence to aftercare among people with mental disorders.

Objective: To identify evidence from comparative studies on the effects of psychiatric guideline implementation on provider performance and patient outcome. Effects of different implementation strategies were reviewed., Method: Articles published between 1966 and March 2006 were searched through electronic databases and hand search. A systematic review of comparative studies of structured implementation of specific psychiatric guidelines was performed. Rates of guideline adherence, provider performance data, illness detection and diagnostic accuracy rates were extracted in addition to patient relevant outcome data., Results: Eighteen studies (nine randomized-controlled trials, six non-randomized-controlled studies and three quasiexperimental before-and-after studies) were identified. Effects on provider performance or patient outcome were moderate and temporary in most cases. Studies with positive outcomes used complex multifaceted interventions or specific psychological methods to implement guidelines., Conclusion: There is insufficient high-quality evidence to draw firm conclusions on the effects of implementation of specific psychiatric guidelines.

Objective: To compare the health relevant behavior of psychiatric patients and the general population., Method: Health behavior of 363 psychiatric in-patients with ICD-10 diagnoses of schizophrenia, bipolar disorders, major depressive disorders and neurotic, and somatoform disorders was compared with health behavior of a representative sample of 7200 persons from German general population., Results: Increased prevalence rates for smoking and illicit drug use were found for all diagnostic groups. Risk alcohol consumption was increased in patients with schizophrenia and depression. Smokers with schizophrenia had an excess cigarette consumption compared with general population. The number of unhealthy food habits was increased in all diagnostic groups, and the body mass index was found to be increased for patients with schizophrenia. Patients with depression were more physically active than general population., Conclusion: Poor health behavior is widespread in patients with all major psychiatric diagnoses. Interventions to reduce risk behavior and strengthen health preventive lifestyles are necessary.

Objective: The aim of the study was the longitudinal analysis of the influence of social and clinical factors on the mid-term costs of schizophrenia treatment., Method: Treatment costs as well as clinical and social characteristics of 307 patients with the ICD-10 diagnosis of schizophrenia were assessed at five follow-ups over 2.5 years. Between and within effects of clinical and social characteristics on treatment costs were estimated by error component regression models., Results: Effects caused by differences between individuals were found for age, partnership, in-patient history, objective and subjective role functioning, life-events and psychotic relapse. Effects of idiosyncratic transitory changes of social and clinical characteristics were found for symptoms, psychotic relapse, and for social role-functioning., Conclusion: Treatment costs can be reduced to a limited extent not only by the prevention of psychotic symptoms and relapse but also by the improvement of role-functioning capacities.

Objective: To compare subjective quality of life (QOL) and objective QOL indicators in patients with schizophrenia from five European sites: Amsterdam, Copenhagen, London, Santander and Verona., Method: A representative sample of 404 patients with schizophrenia, in contact with mental health services, was randomly selected and evaluated with the Lancashire Quality of Life Profile (EU)., Results: The level of satisfaction in certain domains, religion, family and social relations appears to be associated with local style of living and culture while work, finances, and safety were more independent from local variations. In addition to the severity of symptoms, frequency of contacts with family, friendship and age appear as predictors of QOL, all of them influenced by the characteristics of the surroundings., Conclusion: The centres participating in the study presented differences in subjective measures of QOL, objective indicators and also in service provision and styles of living.

Objective: To compare service utilization and cost profiles of people with schizophrenia living in Europe in order to understand differences in treatment and care costs., Method: Cross-sectional samples were taken of people with schizophrenia in five European locations. Sociodemographic, clinical and service use data were collected via interviewer-administered questionnaires. Site-specific unit costs were obtained, transformed subsequently into a single currency (UK pound). Multiple regression analyses were conducted., Results: There were widespread and considerable differences between sites in service utilization patterns and associated costs. Higher needs, greater symptom severity and longer psychiatric history are associated with higher costs: quality of life and service satisfaction are not. Few differences were found between sites in patterns of association with cost., Conclusion: Comparative analyses of the use and cost of mental health services can highlight existing variations helpfully in service provision and uptake. Methodological consistency is required if meaningful conclusions are to be drawn from such comparative data.

Objective: To compare the occurrence of needs of patients with schizophrenia in Amsterdam, Copenhagen, London, Santander and Verona., Method: Patients with schizophrenia were interviewed with the Camberwell Assessment of Need. The mean numbers of total, met and unmet needs were compared across the sites. Ratings for individual domains were also examined. Means were adjusted, using multiple regression analysis, to control for patient differences between sites., Results: The highest levels of unmet need were in Amsterdam and London. The number of met needs were similar. Adjusting for patient differences reduced the estimated number of unmet needs and total needs in Copenhagen, but made little difference elsewhere. There were many site differences for individual domains., Conclusion: Needs vary between different countries. Unmet needs are greater in large urban areas like London and Amsterdam. Differences in the pattern of individual needs may be partly explained in terms of service provision.