Search

Background and Hypothesis Meta-analyses have shown that the majority of patients with schizophrenia who have not improved after 2 weeks of treatment with an antipsychotic drug are unlikely to fully respond later. We hypothesized that switching to another antipsychotic with a different receptor binding profile is an effective strategy in such a situation. Study Design In total, 327 inpatients with an acute exacerbation of schizophrenia were randomized to double-blind treatment with either olanzapine (5–20 mg/day) or amisulpride (200–800 mg/day). Those patients who had not reached at least 25% Positive-and-Negative-Syndrome-Scale (PANSS) total score reduction from baseline after 2 weeks (the “non-improvers”) were rerandomized double-blind to either staying on the same compound (“stayers”) or to switching to the other antipsychotic (“switchers”) for another 6 weeks. The primary outcome was the difference in the number of patients in symptomatic remission between the combined “switchers” and the “stayers” after 8 weeks of treatment, analyzed by logistic regression. Study Results A total of 142 nonimprovers were rerandomized at week two. 25 (45.5 %) of the ‘stayers' compared to 41 (68.3 %) of the “switchers” reached remission at endpoint (p = .006). Differences in secondary efficacy outcomes were not significant, except for the PANSS negative subscore and the Clinical-Global-Impression-Scale. “Switchers” and “stayers” did not differ in safety outcomes. Conclusions Switching “non-improvers” from amisulpride to olanzapine or vice-versa increased remission rates and was safe. The superiority in the primary outcome was, however, not paralleled by significant differences in most secondary efficacy outcomes and the effect was only apparent at the last visit making replications of longer duration necessary.

Zusammenfassung Ziel der Studie Untersucht werden der subjektive Stellenwert und Erfahrungen mit der Bewegungs- und Sporttherapie (BST) bei Patienten mit schweren psychischen Erkrankungen. Methodik Querschnittserhebung bei Patienten mit schweren psychischen Erkrankungen (18 bis 65 Jahre, N=385). Untersuchung möglicher Zusammenhänge zwischen dem subjektiven Stellenwert der BST und soziodemografischen und krankheitsassoziierten Variablen durch eine binäre logistische Regression. Ergebnisse 84,4% der Befragten (n=325) schätzen den Stellenwert einer BST als hoch ein. Ein noch größerer Anteil der Befragten (90,6%, n=349) konnte bereits Erfahrungen mit einer entsprechenden Therapie sammeln. Studienteilnehmende mit einem höheren Funktionsniveau (höherer GAF-Wert, p=0,041) und wohnhaft in einem großstädtischem Wohnumfeld (p=0,011) maßen der BST einen höheren subjektiven Stellenwert bei. 44,1% (n=143) der Befragten, die den BST einen hohen subjektiven Stellenwert beimessen, treiben regelmäßig Sport. Schlussfolgerung Die meisten der hier befragten schwer psychisch kranken Menschen messen den BST einen überraschend hohen Stellenwert bei. Dies erweist sich vor dem Hintergrund der zunehmenden Evidenz zu den positiven Effekten dieser Therapien als exzellenter Ansatzpunkt, diese im Gesamtbehandlungsplan fester zu verankern. Gleichzeitig gilt es, Strategien für einen Alltagstransfer stärker zu implementieren.

Antipsychotic drugs are the mainstay of treatment of schizophrenia, and are known to reduce acute symptoms of the disorder. An original version of the current review, published in 2012, examined whether antipsychotics are effective for relapse prevention, compared to withdrawing these agents for people with schizophrenia or schizophrenia-like psychoses, based on evidence from randomized trials. The current report of the update of the review is focused on some newly investigated outcomes: rates of remission and recovery, change in social functioning and in quality of life. The updated review included 75 randomized controlled trials (RCTs) published from 1959 to 2017, involving 9145 participants. Although some potential sources of bias limited the overall quality, the efficacy of antipsychotic drugs for maintenance treatment in schizophrenia was clear and robust to a series of sensitivity analyses. Antipsychotic drugs were more effective than placebo in preventing relapse at 1 year (drug 24% versus placebo 61%, 30 RCTs, n = 4249, RR = 0.38, 95% CI = 0.32 to 0.45) and in reducing hospitalization (drug 7% versus placebo 18%, 21 RCTs, n = 3558, RR = 0.43, 95% CI = 0.32 to 0.57). Quality of life appeared to be better in drug-treated participants (7 RCTs, n = 1573, SMD = −0.32, 95% CI = −0.57 to −0.07); the same for social functioning (15 RCTs, n = 3588, SMD = −0.43, 95% CI = −0.53 to −0.34). Although based on data from fewer studies, maintenance treatment apparently increased the possibility to achieve remission of symptoms (drug 53%, placebo 31%; 7 RCTs, 867 participants; RR = 1.73, 95% CI = 1.20 to 2.48) and to sustain it over 6 months (drug 36%, placebo 26%; 8 RCTs, 1807 participants; RR = 1.67, 95% CI = 1.28 to 2.19). There were no data on recovery. Antipsychotic drugs as a group were associated with more participants experiencing side effects such as movement disorders (e.g., at least one movement disorder: drug 14% versus placebo 8%, 29 RCTs, n = 5276, RR 1.52, 95% CI = 1.25 to 1.85) and weight gain (drug 9% versus placebo 6%, 19 RCTs, n = 4767, RR = 1.69, 95% CI = 1.21 to 2.35, NNTH = 25, 95% CI = 20 to 50). For people with schizophrenia, the evidence suggests that maintenance on antipsychotic drugs does not only prevent relapses and rehospitalizations, but that patients also benefit in terms of quality of life, functioning and sustained remission. These positive effects must be weighed against the backdrop of the adverse effects of antipsychotics.

Rationale Weight gain is a frequent side effect of treatment with SGAs (second-generation antipsychotics) and a leading cause for nonadherence. Several candidate genes have been identified that could influence the amount of AIWG (antipsychotic-induced weight gain). The polymorphism rs17782313 near the MC4R (human melanocortin 4 receptor gene) was strongly associated with obesity in a large scale GWAS (genome wide association study), yet previous studies investigating its impact on AIWG did not lead to a definite conclusion regarding its effect. In particular, they were all relatively short and had a naturalistic design. Objective We therefore examined the influence of the rs17782313 polymorphism on SGA-related weight gain. Methods Participants of a multicenter randomized, controlled, double-blind study comparing two treatment strategies in individuals with schizophrenia or schizoaffective disorder were genotyped using a rapid-cycle polymerase chain reaction. Up to 252 individuals completed the first 2 weeks (phase I), 212 the entire 8 weeks (hence ‘completers’). Patients received either amisulpride or olanzapine or both consecutively. Thirty-seven had their first episode. Weight gain occurring in different genotypes was statistically compared and confounding factors were adjusted by stepwise multiple linear regression. A correction for multiple testing was included. Results Within 212 ‘completers’, carriers of the C allele had a higher absolute weight gain than those homozygous for the T allele (2.6 kg vs. 1.2 kg), though this observation was not significant (P = 0.063). In the amisulpride subpopulation, this association appeared stronger and reached significance (2.5 kg vs. 0.7 kg, P = 0.043), though failed to remain significant after correction for multiple testing. A stepwise multiple linear regression showed a significant association in both the whole study population (P < 0.001) and the amisulpride subpopulation (P < 0.001). Conclusion Our results indicate that the rs17782313 polymorphism might influence antipsychotic-induced weight gain and therefore confirm some of the earlier conclusions.

The CATIE schizophrenia trial was a very influential randomized controlled trial in patients with chronic schizophrenia. Patients were followed for up to 18 months under treatment with a randomly assigned antipsychotic. The primary endpoint, time to discontinuation of treatment for any reason, is influenced by individual patient characteristics, external factors as well as effects of drug treatment. New insight is obtained by applying an innovative survival analysis based on constrained confidence partitioning (SA-C

Zusammenfassung Ziel der Studie Genesungsbegleitung spielt in der Behandlung schwer psychisch erkrankter Menschen eine zunehmende Rolle. Zur Wirksamkeit liegen internationale Befunde vor. Über Wissen, Nutzung und Nutzenbewertung ist in Deutschland bisher wenig bekannt. Die vorliegende Arbeit geht dieser Frage nach und stellt Ergebnisse aus einer Beobachtungsstudie mit 10 teilnehmenden Zentren in Süddeutschland vor. Methodik Im Rahmen der beobachtenden Querschnittsstudie mit schwer psychisch erkrankten Menschen (IMPPETUS, N=359) wurden zwischen März und September 2019 soziodemografische sowie krankheits- und behandlungsassoziierte Daten erhoben. Mittels binär logistischer Regression wurde ein möglicher Zusammenhang mit der Nutzung von Genesungsbegleitung analysiert. Ergebnisse 38% (N=138) der Befragten gaben an, von der Möglichkeit der Genesungsbegleitung zu wissen; 15% (N=55) bejahten deren Nutzung. Eine Nutzung schwankte zwischen 6,5 und 37,5% über die Standorte und war mit dem Haushaltseinkommen verbunden. Deutlich seltener wurde Genesungsbegleitung von Personen mit einem hohen gegenüber Personen mit einem geringen Haushaltseinkommen genutzt (OR=0,20 [95% CI: 0,06–0,68], p=0,01). Von den Nutzenden (N=55) gaben 78% an, diese als hilfreich bzw. äußerst hilfreich wahrgenommen zu haben. Diskussion Genesungsbegleitung erweist sich nicht nur unter Studienbedingungen hinsichtlich verschiedener Outcomes als wirksam, sondern wird auch unter Routinebedingungen in einer umschriebenen Versorgungsregion von der Mehrheit der Nutzenden als wirksam eingeschätzt. Allerdings müssen Wissen und Nutzung hinsichtlich einer Genesungsbegleitung unter (teil)stationär behandelten Personen als gering verteilt bewertet werden. Schlussfolgerung Um Genesungsbegleitung stärker in die Praxis zu implementieren, muss wirksamer als bisher über dieses Unterstützungsangebot informiert und ein (über-)regionaler Austausch über erfolgreiche Implementierungserfahrungen angestrengt werden.

Assessing the experience with and the attitudes towards exercise therapy in persons with severe mental illness (SMI). Furthermore, potential variables of high preference towards exercise therapy are investigated.Cross-sectional observational study of SMI patients aged between 18 and 65 years (n=385). Patients were interviewed by trained staff using standardised instruments. Potential variables were analysed using a hierarchic binary logistic regression model.84,4% of SMI patients had a high preference for exercise therapy; of these, 44,1% exercised regularly. Among patients with severe mental illness especially a higher value in the GAF-assessment (p=0,041) and living in a metropolitan area (p=0,011) predict a high preference for exercise therapy.Most of the patients with severe mental illness interviewed in this study place a surprisingly high value on sports and exercise therapy. Due to the increasing evidence with regard to positive effects of these therapies, it may be an excellent starting point to expand sports and exercise therapy as part of a comprehensive treatment plan. At the same time, strategies for everyday transfer need to be implemented more rigorously.Untersucht werden der subjektive Stellenwert und Erfahrungen mit der Bewegungs- und Sporttherapie (BST) bei Patienten mit schweren psychischen Erkrankungen.Querschnittserhebung bei Patienten mit schweren psychischen Erkrankungen (18 bis 65 Jahre, N=385). Untersuchung möglicher Zusammenhänge zwischen dem subjektiven Stellenwert der BST und soziodemografischen und krankheitsassoziierten Variablen durch eine binäre logistische Regression.84,4% der Befragten (n=325) schätzen den Stellenwert einer BST als hoch ein. Ein noch größerer Anteil der Befragten (90,6%, n=349) konnte bereits Erfahrungen mit einer entsprechenden Therapie sammeln. Studienteilnehmende mit einem höheren Funktionsniveau (höherer GAF-Wert, p=0,041) und wohnhaft in einem großstädtischem Wohnumfeld (p=0,011) maßen der BST einen höheren subjektiven Stellenwert bei. 44,1% (n=143) der Befragten, die den BST einen hohen subjektiven Stellenwert beimessen, treiben regelmäßig Sport.Die meisten der hier befragten schwer psychisch kranken Menschen messen den BST einen überraschend hohen Stellenwert bei. Dies erweist sich vor dem Hintergrund der zunehmenden Evidenz zu den positiven Effekten dieser Therapien als exzellenter Ansatzpunkt, diese im Gesamtbehandlungsplan fester zu verankern. Gleichzeitig gilt es, Strategien für einen Alltagstransfer stärker zu implementieren.

ZUSAMMENFASSUNGDas Schwabinger Modell wurde für die speziellen Bedürfnisse der Patienten einer allgemeinpsychiatrischen Sektorenklinik entwickelt. Es besteht aus 4 theoretischen Säulen, die den Mitarbeitern Orientierung geben sollen: die durch andere Modelle moderner Psychiatrie fundierte therapeutische Haltung, Kenntnisse des Deeskalationstrainings, der gezielte Einsatz von Dolmetscherdiensten sowie ein motivierter Arbeitsgeist. Im Rahmen eines Both-directions-Ansatzes des Veränderungsmanagements konnten erste Erfolge in der Etablierung eines solchen Modells erreicht werden. Widerstände unter den Mitarbeitern sollten durch eine gezielte Fortführung des Modells im Bottom-up-Prozess, nämlich der Schulung der Mitarbeiter, minimiert werden.

ZUSAMMENFASSUNGZiel: Patienten, die an einer schwerwiegenden psychiatrischen Erkrankung leiden, werden von den behandelnden Psychiatern oft nicht im Rahmen einer partizipativen Entscheidungsfindung (shared decision making, SDM) mit in die Entscheidungsprozesse einbezogen. Da SDM auch die Behandlungsergebnisse in der Therapie psychiatrischer Erkrankungen verbessern könnte, untersucht die dargestellte Studie (SDMPLUS) die Anwendung von SDM im Bereich akut erkrankter Patienten.Methodik: In dieser multizentrischen, cluster-randomisierten Studie wurde der Einsatz von SDMPLUS gegenüber der Standardbehandlung auf 12 akutpsychiatrischen Stationen in 5 Kliniken untersucht. Alle Patienten, die an einer schizoaffektiven Störung oder einer Schizophrenie litten und die Einschlusskriterien der Studie erfüllten, wurden bei Aufnahme auf die Stationen konsekutiv in die Studie eingeschlossen. Auf den Interventionsstationen erhielten sie ein Gruppentraining in den Kommunikationstechniken des SDMPLUS. Die Behandlungsteams dieser Stationen durchliefen 2 halbtägige Workshops zum Erwerb der Techniken. Auf den Kontrollstationen wurden weder Patienten noch Behandlungsteams trainiert, die Behandlung verlief unverändert („treatment as usual“, TAU). Der primäre Zielparameter der Studie war das Ausmaß der subjektiv empfundenen Einbeziehung in die Entscheidungsfindungsprozesse der Patienten nach 3 Wochen. Retrospektiv wurden in einer Post-hoc-Analyse Daten zu Aggressionshandlungen und freiheitsentziehenden Maßnahmen nacherhoben und ausgewertet.Ergebnis: Insgesamt wurden je 161 Patienten auf den Interventions- und Kontrollstationen in die Studie aufgenommen. Die Intervention SDMPLUS führte zu einem höheren Maß an empfundener Einbeziehung in die Entscheidungsprozesse, dargestellt durch einen mittleren Unterschied von 16,5 Punkten in der SMD-Q-9-Skala. Darüber hinaus waren die therapeutische Allianz, die Zufriedenheit mit der Behandlung und die selbstberichtete Adhärenz der Interventionspatienten höher als in der Kontrollgruppe. Allerdings fanden sich in der Nachbeobachtungsphase über die Dauer eines Jahres hinweg keine Hinweise auf eine Erhöhung der Adhärenz oder eine Reduktion der Rehospitalisierungsraten. Auch zeigte die Intervention keine direkte Auswirkung auf das Auftreten von Aggressionshandlungen oder die Anwendung von freiheitsentziehenden Maßnahmen oder Zwangsbehandlungen. Patienten mit einer dokumentierten Aggressionshandlungen oder der Aufnahme in die stationäre Behandlung entgegen ihrem Willen konnten jedoch in gleichem Ausmaß von der Intervention hinsichtlich der erlebten Einbeziehung in Entscheidungsprozesse profitieren wie die restlichen Teilnehmer der Studie.Zusammenfassung: Die Studie konnte zeigen, dass die Kommunikationstechniken des SDMPLUS (z. B. auch das Einbeziehen von Elementen der motivierenden Gesprächsführung) eine Möglichkeit darstellen, die partizipative Entscheidungsfindung auch im akutpsychiatrischen Behandlungskontext im Interesse der Patienten einzusetzen. Die Schnittstellenproblematik zwischen der stationären und der post-stationären Behandlung muss hierbei aber künftig noch stärker in den Fokus genommen werden, um die Effekte nachhaltig zu festigen.

ZUSAMMENFASSUNG Ziele Die Einbeziehung von Angehörigen in die stationär-psychiatrische Behandlung wurde kaum durch repräsentative Studien untersucht. Ziel dieser Studie war es daher, die Einbeziehung von Angehörigen in die stationär-psychiatrische Routineversorgung anhand einer repräsentativen Stichprobe unter Beteiligung aller 3 Parteien (Patienten, Psychiater und Angehörige) zu untersuchen. Mit Hilfe von persönlich durchgeführten Interviews, bestehend aus geschlossenen und offenen Fragen, wollten wir ein tieferes Verständnis dafür gewinnen, wann Angehörige in die Behandlung einbezogen werden und welche Themen hauptsächlich zur Sprache kommen. Methoden In diese Querschnittsstudie wurden Patienten von 55 akut-psychiatrischen Stationen aus 10 psychiatrischen Kliniken, die behandelnden Psychiater und, wenn möglich, die zugehörigen Angehörigen einbezogen. Jeder Psychiater nannte zunächst 2–3 Patienten, die kurz vor der Entlassung standen, diese Patienten wurden um Studienteilnahme gebeten. Nachdem ein Patient in die Studienteilnahme eingewilligt hatte, wurde ein persönliches Interview durch einen Forscher durchgeführt. Zusätzlich wurde der behandelnde Psychiater und, wenn möglich, ein vom Patienten benannter Angehöriger befragt. Insgesamt konnten 247 Patienten und 247 Psychiater sowie 94 Angehörige in unsere Studie eingeschlossen werden. Ergebnisse Laut Patienten und Psychiater fand ein Kontakt zwischen Angehörigen und Psychiatern nur in einem Drittel der Fälle statt. Prädiktoren für den Arzt-Angehörigen-Kontakt waren die Diagnose des Patienten, die Anzahl der vorherigen stationär-psychiatrischen Aufenthalte und das behandelnde Krankenhaus. Nach Angaben der Psychiater wurden mit den Angehörigen am häufigsten therapeutische Fragestellungen besprochen sowie organisatorische und sozialpsychiatrische Themen geklärt. Patienten und Angehörige gaben dagegen an, dass die psychiatrische Behandlung und die diagnostische Einordnung der psychischen Erkrankung die häufigsten Gesprächsthemen waren. Die subjektive Wahrnehmung, dass die Einbeziehung eines Angehörigen in die Behandlung nicht notwendig ist, war der in allen Gruppen am häufigsten genannte Grund für eine ausbleibende Einbeziehung. Schlussfolgerung Ob ein Kontakt zwischen Angehörigen und Psychiatern stattfindet hängt stark vom zuständigen Krankenhaus ab. Daher könnte die Einbeziehung von Angehörigen in die stationär-psychiatrische Behandlung dadurch verbessert werden, dass bestehende Strukturen und Abläufe im Krankenhaus verändert werden. Auch ob Angehörige während eines stationären Aufenthaltes kontaktiert und einbezogen wurden, hing stark von der jeweiligen Klinik ab. Alle Parteien (Patienten, Angehörige und Psychiater) gaben zudem am häufigsten an, dass Angehörige nicht in die Behandlung einbezogen wurden, da dies unnötig sei. Dies steht im klaren Gegensatz zur existierenden Evidenz, welche zeigt, dass eine Angehörigeneinbeziehung einen positiven Einfluss auf den Behandlungsverlauf und das Wohlbefinden der Angehörigen selbst hat. Es ist daher notwendig, Wissen über die positiven Effekte der Angehörigeneinbeziehung zu vermitteln.

Purpose People with a severe mental illness (SMI) are at particular risk of occupational exclusion. Among the approaches to occupational rehabilitation, supported employment (SE) has been proven to be the most effective. A requirement to enter SE-programs is that individuals must want to seek competitive employment. The aim of this work is to investigate the relationship between serious mental illness and the desire to work including potential predictors. Methods This is a cross-sectional observational study of patients with SMI aged 18–65 years (n = 397). Patients were interviewed by trained staff using standardised instruments. The relationship between potential predictors and a strong preference for employment were analysed using a hierarchic binary logistic regression model. Results Only about one-quarter (27.9%) of SMI patients is in competitive employment. Another quarter is unemployed (25.9%). Results show that the desire for competitive employment is strong among more than half of the SMI patients. Among the unemployed, two-thirds express a strong desire for work. These individuals are an ideal target group for SE interventions. Comorbid chronic physical illness, diagnosis, and the subjectively judged ability to work are associated with the desire for work. Conclusion Our data confirm a substantial exclusion of individuals with SMI from the workforce. In general, care needs for workplace interventions are not being met and leave much room for improvement. In addition to employment status, the desire for work should be routinely assessed. Study registration The study was registered in the German Clinical Trials Register (DRKS) (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00015801) and under the WHO-Platform “International Clinical Trials Registry Platform” (ICTRP) (https://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00015801) under the registration number DRKS00015801 before the start of recruitment (Registration date: 21.02.2019).

Zusammenfassung Hintergrund Ebenso wie die World Psychiatric Association (WPA) und andere nationale psychiatrische Fachgesellschaften hat auch die Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde (DGPPN) ein Positionspapier zu Religiosität und Spiritualität (R/Sp) in Psychiatrie und Psychotherapie veröffentlicht, in dem sie Patientenzentrierung und spirituelle Kompetenz (SpK) der psychiatrischen Berufe fordert. Es ist bekannt, dass Kompetenzmangel das wichtigste Hindernis für die Implementierung von Spiritual Care (SpC) in die klinische Praxis darstellt. Fragestellung Ziel der vorliegenden Studie ist die praxisnahe Untersuchung der SpK in Psychiatrie und Psychotherapie. Wie schätzen psychiatrisch Tätige die SpK ihrer eigenen Berufsgruppe ein und welche Variablen beeinflussen dieses Urteil? Material und Methoden Insgesamt 391 psychiatrische Pflegekräfte, 75 Psychiater, 119 Therapeuten verschiedener Professionen und 62 andere (n = 647) aus Krankenhäusern in Deutschland und Österreich füllten den SpC Competency Questionnaire (SCCQ) aus. Ergebnisse Pflegekräfte, ältere und spirituell erfahrenere Personen schätzen die SpK der eigenen Berufsgruppe vergleichsweise höher ein und meinen seltener, diesbezüglich nicht zuständig zu sein. Pflegende nennen häufiger als andere Berufsgruppen das Fehlen geeigneter Räumlichkeiten als Hindernis für die Implementierung von SpC. Höhere Einschätzung der SpK der eigenen Berufsgruppe geht mit höheren Werten in den SCCQ-Faktoren „Selbsterfahrung und proaktive Öffnung“, „Team-Spirit“, „Wahrnehmungs‑/Dokumentationskompetenz“ einher. Diskussion Die Zuständigkeit der Gesundheitsberufe für SpC in Psychiatrie und Psychotherapie wird unter den deutschsprachigen psychiatrischen Berufsgruppen noch kontrovers diskutiert. Dies hängt mit mangelnder Kompetenz in diesem Feld zusammen.

Some, but not all, studies have found longer duration of untreated psychosis (DUP) to be associated with poor response to treatment and more severe negative symptoms in schizophrenia. The aim of the current analysis was to investigate these parameters in a large cohort of patients in their first psychotic episode. The OPTiMiSE cohort included 446 patients with DUP up to two years, who were administered amisulpride for 4 weeks (Phase I). Patients who did not meet Andreasen remission criteria were randomized to double-blind continuation of amisulpride or olanzapine for 6 additional weeks in a blinded study (Phase II). Analyses showed that shorter DUP was associated with lower baseline CGI scores (p0.001, r = 0.184), PANSS total (p = 0.025, r = 0.106) and PANSS negative subscale scores (p = 0.023, r = 0.107). Remitters had a significantly shorter mean DUP compared to non-remitters both in Phase I (24.5 weeks ±24.3 vs. 35 weeks ± 32.2, p = 0.01, t=-2.521) and in Phase II (24.3 weeks ± 26.4 vs. 38.3 weeks ± 31.3, p = 0.031, t=-2.194). Logistic regression analyses showed a significant effect of DUP on treatment response both in phase I (p = 0.008) and phase II (p = 0.041). Linear regression analyses found that DUP significantly affects PANSS Total change at the end of phase I (p = 0.028) but not at the end of phase II (p = 0.236). Based on these findings, it is possible to conclude that shorter DUP is associated with better response to treatment, particularly during the first weeks after treatment initiation. These findings highlight the need for early identification of the first psychotic episode.

Background The German guideline on psychosocial interventions for people with severe mental disorders recommends a broad spectrum of evidence-based treatments. Structured implementation of the associated patient version of the guideline is missing to date. The study aims to assess whether structured implementation of a patient guideline improves the empowerment of patients with severe mental disorders, as well as knowledge, attitudes and experiences regarding psychosocial interventions, service use, treatment satisfaction, treatment needs, quality of life and burden of care. Methods The study is a multicentre, cluster-randomised, controlled study with two parallel groups. Inpatients and day hospital patients (all sexes; 18–65 years) with severe mental disorders will be included. Additionally, relatives of patients with mental disorders (all sexes; ≥ 18 years) will be included. In the experimental group, the patient guideline will be implemented using a multimodal strategy. Participants in the control group will receive treatment as usual but will be made aware of the patient guideline. The primary outcome is the change of empowerment, assessed by using the ‘empowerment in the process of psychiatric treatment of patients with affective and schizophrenia disorders’ (EPAS) scale. In addition, knowledge, attitudes and experiences regarding psychosocial interventions will be assessed as secondary outcomes, as well as service use, satisfaction with care, patient need and quality of life and participation and social inclusion. For relatives, the perceived burden of care also will be recorded. Results will be analysed using hierarchical linear models. For the health economic evaluation, the incremental cost-utility ratios will be computed using the differences in total costs of illness and the differences in quality-adjusted life years (QALY) between study groups. Discussion The study will be the first to assess the effects of a structured implementation of the patient version of a psychiatric treatment guideline. The study has some limitations regarding the transferability of the results to other patients and other regions. Furthermore, problems with the recruitment of patients and relatives and with the implementation of intervention could occur during the study. Trial registration The study is registered in the German Clinical Trials Register (DRKS) and the WHO International Clinical Trials Registry Platform (ICTRP) under registration number DRKS00017577 (Date of registration: 23 October 2019.

Peer support is playing an increasing role in the treatment of severely mentally ill people. International findings are available on its effectiveness. However, little is known about knowledge, use and benefit assessment in Germany. This paper addresses this question and presents results from an observational study with 10 participating clinics in southern Germany.As part of the observational cross-sectional study with people with severe mental illness (IMPPETUS, N=359), sociodemographic and illness- and treatment-associated data were collected by trained study staff between March 2019 and September 2019. Binary logistic regression was used to analyse a possible association with peer support use.38% (N=138) of respondents reported knowledge about the possibility of peer support; 15% (N=55) affirmed its use. Use of peer support varied across sites (between 6.5 and 37.5%) and was associated with household income. Significantly less frequent use of peer support was among those with high versus low household income (OR=0.20 [95% CI: 0.06-0.68], p=0.01). Of respondents with peer support use (N=55), 78% reported perceiving peer support to be helpful or highly helpful.Peer support not only proves to be effective under study conditions with regard to various outcomes, but is also assessed as beneficial under routine conditions in a defined care region by the majority of users. However, only a few respondents knew and used the possibility of peer support.In order to implement peer support more strongly, information about this kind of service should be provided more effectively and a dialogue about successful implementation experiences should be initiated on a regional level.Genesungsbegleitung spielt in der Behandlung schwer psychisch erkrankter Menschen eine zunehmende Rolle. Zur Wirksamkeit liegen internationale Befunde vor. Über Wissen, Nutzung und Nutzenbewertung ist in Deutschland bisher wenig bekannt. Die vorliegende Arbeit geht dieser Frage nach und stellt Ergebnisse aus einer Beobachtungsstudie mit 10 teilnehmenden Zentren in Süddeutschland vor.Im Rahmen der beobachtenden Querschnittsstudie mit schwer psychisch erkrankten Menschen (IMPPETUS, N=359) wurden zwischen März und September 2019 soziodemografische sowie krankheits- und behandlungsassoziierte Daten erhoben. Mittels binär logistischer Regression wurde ein möglicher Zusammenhang mit der Nutzung von Genesungsbegleitung analysiert.38% (N=138) der Befragten gaben an, von der Möglichkeit der Genesungsbegleitung zu wissen; 15% (N=55) bejahten deren Nutzung. Eine Nutzung schwankte zwischen 6,5 und 37,5% über die Standorte und war mit dem Haushaltseinkommen verbunden. Deutlich seltener wurde Genesungsbegleitung von Personen mit einem hohen gegenüber Personen mit einem geringen Haushaltseinkommen genutzt (OR=0,20 [95% CI: 0,06–0,68], p=0,01). Von den Nutzenden (N=55) gaben 78% an, diese als hilfreich bzw. äußerst hilfreich wahrgenommen zu haben.Genesungsbegleitung erweist sich nicht nur unter Studienbedingungen hinsichtlich verschiedener Outcomes als wirksam, sondern wird auch unter Routinebedingungen in einer umschriebenen Versorgungsregion von der Mehrheit der Nutzenden als wirksam eingeschätzt. Allerdings müssen Wissen und Nutzung hinsichtlich einer Genesungsbegleitung unter (teil)stationär behandelten Personen als gering verteilt bewertet werden.Um Genesungsbegleitung stärker in die Praxis zu implementieren, muss wirksamer als bisher über dieses Unterstützungsangebot informiert und ein (über-)regionaler Austausch über erfolgreiche Implementierungserfahrungen angestrengt werden.

Combining antipsychotics is common in schizophrenia treatment, despite evidence-based guidelines generally not recommending such practice. Otherwise, evidence remains inconclusive, especially regarding specific combinations. The trial aimed to test whether a combination of amisulpride plus olanzapine is more effective than either intervention as a monotherapy.A multicentre, 16-week, randomised, double-blind, controlled trial was done at 16 psychiatric in-patient centres throughout Germany. Inclusion criteria were adults aged 18-65 years with non-first episode schizophrenia or schizoaffective disorder and with a Positive and Negative Syndrome Scale (PANSS) total score of at least 70 and at least two items of the positive symptoms subscale rated at least 4. Patients were randomly assigned to receive 16 weeks of treatment with either amisulpride plus olanzapine, amisulpride plus placebo, or olanzapine plus placebo (1:1:1), and block randomisation was stratified by study site. To keep patients and investigators masked throughout the duration of the trial, amisulpride, olanzapine, and placebo were administered as identical capsules. Flexibly dosed monotherapy of oral amisulpride (amisulpride plus placebo, 200-800 mg per day) or olanzapine (olanzapine plus placebo, 5-20 mg per day) was compared with a combination of amisulpride plus olanzapine. The primary outcome was symptom reduction measured by the PANSS total score after 8 weeks, in the modified intention-to-treat population (all patients randomly assigned to an intervention and receiving at least one study drug dose). As determined a priori, group differences were examined by t tests (Bonferroni-Holm-adjustment) followed by pre-planned Bayesian analyses as well as imputation methods based on mixed models to account for missing values and post-hoc ANCOVA adjusting for PANSS baseline scores. The study was registered on ClinicalTrials.gov, NCT01609153; the German Clinical Trials Register, DRKS00003603; and the European Union Drug Regulating Authorities Clinical Trials Database, EudraCT-No. 2011-002463-20.Between June 15, 2012, and Dec 15, 2018, 13 692 patients were assessed for eligibility. 13 364 patients were excluded (including for not meeting inclusion criteria, declining to participate, or inappropriate reasons for changing pharmacological treatment), and 328 were then randomly assigned to an intervention group. 112 patients were randomly assigned to receive amisulpride plus olanzapine, 109 were randomly assigned to receive amisulpride plus placebo, and 107 were randomly assigned to receive olanzapine plus placebo. 321 patients were analysed for the primary outcome in the modified intention-to-treat population after exclusion of screening failures and patients who did not receive the intervention (110 for amisulpride plus olanzapine, 109 for amisulpride plus placebo, and 102 for olanzapine plus placebo). Among the 321 patients who were randomly assigned to intervention groups and analysed for the primary outcome, 229 (71%) were male, 92 (29%) were female; the mean age was 40·2 years (SD 11·7); and 296 (92%) were White and 25 (8%) were classified as other ethnicity. PANSS total score improved significantly more at 8 weeks in the amisulpride plus olanzapine group (-29·6 [SD 14·5]) than in the olanzapine plus placebo group (-24·1 [13·4], p=0·049, Cohen's d=0·396). A significant difference was not observed in reduction of PANSS total score between the amisulpride and olanzapine group compared with the amisulpride and placebo group (-25·2 [SD 15·9], p=0·095, Cohen's d=0·29). After 8 weeks and 16 weeks, sexual dysfunction, weight, and waist circumference increase were significantly higher for patients receiving amisulpride plus olanzapine than for those receiving amisulpride plus placebo, with no differences in serious adverse events. Two patients died during study participation; one randomly assigned to the amisulpride plus olanzapine group, and one assigned to the olanzapine plus placebo group (both assessed with no relation to treatment).The advantages of amisulpride plus olanzapine have to be weighed against a higher propensity for side-effects. The use of this specific combination therapy could be an alternative to monotherapy in certain clinical situations, but side-effects should be considered.German Federal Ministry of Education and Research.

Employment is of great importance as it is associated with various positive effects. Individuals with severe mental illness (SMI) are often excluded from competitive employment. Current data on employment of individuals with mental illness are rare, and influencing factors are under-researched. The present study examines possible predictors of competitive employment among individuals with SMI.This was a cross-sectional and multicentered study of 300 individuals with SMI aged 18 to 65 years. The following inclusion criteria were used: (I) diagnosis of schizophrenia, schizotypal and delusional disorders (ICD-10 F2x), or affective disorders (ICD-10 F3x), (II) duration of psychiatric illness ≥ 2 years, and (III) substantial impact of illness on social functioning. Participants were interviewed by trained staff using standardised instruments. The relationship between potential predictors (age, sex, education, marital status, living situation, migration background, psychosocial functioning, age at first mental problem, physical illness, work ability) and employment was analysed using a hierarchic binary logistic regression model.Only one-third (34%) of participants were competitively employed. Almost one-third were unemployed (30%), and 28% reported early retirement due to mental illness. Psychosocial functioning was positively associated with competitive employment (OR = 1.09, 95% CI: 1.05 - 1.13, p 0.001); concurrent chronic physical illness was negatively associated with competitive employment (OR = 0.38, 95% CI: 0.21 - 0.71, p = 0.002).Findings confirm a high risk of exclusion from competitive employment among individuals with SMI. Nonetheless, a substantial proportion of individuals are employed. Findings call for efforts to maintain or enhance workforce participation among individuals with SMI. A special focus should be placed on improving physical health and strengthening psychosocial functioning.The study was registered in the German Clinical Trials Register (DRKS) under the registration number DRKS00015801 before the start of recruitment (Registration date: 21.02.2019).Berufliche Beschäftigung ist von großer Bedeutung für den Einzelnen, da sie mit verschiedenen positiven Effekten verbunden ist. Menschen mit schweren psychischen Erkrankungen sind oft vom allgemeinen Arbeitsmarkt ausgeschlossen. Aktuelle Daten zur Beschäftigung von Menschen mit psychischen Erkrankungen liegen kaum vor und die Einflussfaktoren sind bisher wenig erforscht. Die vorliegende Studie untersucht mögliche Prädiktoren für eine wettbewerbsfähige Beschäftigung bei Menschen mit schweren psychischen Erkrankungen.Berichtet werden Ergebnisse einer multizentrischen Querschnittsstudie mit 300 Menschen mit schweren psychischen Erkrankungen im Alter von 18 bis 65 Jahren. Die folgenden Einschlusskriterien wurden verwendet: (I) Diagnose einer Schizophrenie, schizotypen oder wahnhaften Störung (ICD-10 F2x) oder affektiven Störung (ICD-10 F3x), (II) Dauer der psychiatrischen Erkrankung ≥ 2 Jahre und (III) erhebliche Auswirkungen der Erkrankung auf das soziale Funktionsniveau. Die Teilnehmenden wurden von geschultem Personal mit standardisierten Instrumenten befragt. Der Zusammenhang zwischen möglichen Prädiktoren (Alter, Geschlecht, Bildung, Familienstand, Wohnsituation, Migrationshintergrund, psychosoziale Funktionsfähigkeit, Alter bei ersten psychischen Problemen, körperliche Erkrankung, Arbeitsfähigkeit) und der Beschäftigung wurde mittels eines hierarchischen binären logistischen Regressionsmodells analysiert.Nur ein Drittel (34 %) der Teilnehmenden war kompetitiv beschäftigt. Fast ein Drittel der Teilnehmenden war arbeitslos (30 %), und 28 % berichteten über eine Frühverrentung aufgrund der psychischen Erkrankung. Die psychosoziale Funktionsfähigkeit war positiv mit kompetitiver Beschäftigung assoziiert (OR = 1,09, 95% CI: 1,05 - 1,13, p0,001); gleichzeitige chronische körperliche Erkrankungen waren negativ mit kompetitiver Beschäftigung assoziiert (OR = 0,38, 95% CI: 0,21 - 0,71, p = 0,002).Die Ergebnisse bestätigen ein hohes Risiko des Ausschlusses von kompetitiver Beschäftigung bei Menschen mit schwerer psychischer Erkrankung. Gleichwohl ist ein beträchtlicher Anteil beschäftigt. Die Bemühungen, die Erwerbsbeteiligung der Betroffenen zu erhalten bzw. zu erweitern, müssen intensiviert werden. Ein besonderer Fokus sollte dabei auf die körperliche Gesundheit sowie die Stärkung der psychosozialen Funktionen gelegt werden.

BACKGROUND: No established treatment algorithm exists for patients with schizophrenia. Whether switching antipsychotics or early use of clozapine improves outcome in (first-episode) schizophrenia is unknown.METHODS: This three-phase study was done in 27 centres, consisting of general hospitals and psychiatric specialty clinics, in 14 European countries and Israel. Patients aged 18-40 years who met criteria of the DSM-IV for schizophrenia, schizophreniform disorder, or schizoaffective disorder were treated for 4 weeks with up to 800 mg/day amisulpride orally in an open-label design (phase 1). Patients who did not meet symptomatic remission criteria at 4 weeks were randomly assigned to continue amisulpride or switch to olanzapine (≤20 mg/day) during a 6-week double-blind phase, with patients and staff masked to treatment allocation (phase 2). Randomisation was done online by a randomisation website; the application implemented stratification by site and sex, and applied the minimisation method for randomisation. Patients who were not in remission at 10 weeks were given clozapine (≤900 mg/day) for an additional 12 weeks in an open-label design (phase 3). The primary outcome was the number of patients who achieved symptomatic remission at the final visits of phases 1, 2, and 3, measured by intention-to-treat analysis. Data were analysed with a generalised linear mixed model, with a logistic link and binomial error distribution. This trial is registered with ClinicalTrials.gov, number NCT01248195, and closed to accrual.FINDINGS: Between May 26, 2011, and May 15, 2016, we recruited 481 participants who signed informed consent. Of the 446 patients in the intention-to-treat sample, 371 (83%) completed open-label amisulpride treatment, and 250 (56%) achieved remission after phase 1. 93 patients who were not in remission continued to the 6-week double-blind switching trial, with 72 (77%) patients completing the trial (39 on olanzapine and 33 on amisulpride); 15 (45%) patients on amisulpride versus 17 (44%) on olanzapine achieved remission (p=0·87). Of the 40 patients who were not in remission after 10 weeks of treatment, 28 (70%) started on clozapine; 18 (64%) patients completed the 12-week treatment, and five (28%) achieved remission. The number of serious adverse events did not differ between the treatment arms in phase 2: one patient on olanzapine was admitted to hospital because of an epileptic seizure, and one patient on amisulpride was admitted to hospital twice because of exacerbations of psychotic symptoms. Over the course of the trial, two serious suicide attempts were reported.INTERPRETATION: For most patients in the early stages of schizophrenia, symptomatic remission can be achieved using a simple treatment algorithm comprising the sequential administration of amisulpride and clozapine. Since switching to olanzapine did not improve outcome, clozapine should be used after patients fail a single antipsychotic trial-not until two antipsychotics have been tried, as is the current recommendation.FUNDING: European Commission Seventh Framework Program.

As the course of schizophrenic disorders is often chronic, treatment guidelines recommend continuous maintenance treatment to prevent relapses, but antipsychotic drugs can cause many side effects. It, therefore, seems reasonable to try to reduce doses in stable phases of the illness or even try to stop medication. We conducted a 26 weeks, randomized, rater blind, feasibility study to examine individualized antipsychotic dose reduction versus continuous maintenance treatment (Register Number: NCT02307396). We included chronic, adult patients with schizophrenia or schizoaffective disorder, who were treated with any antipsychotic drug except clozapine, who had not been hospitalized in the last 3 years and who were in symptomatic remission at baseline. The primary outcome was relapse of positive symptoms. Symptom severity, social functioning and side effects were also examined as secondary outcomes. 20 patients were randomized. Relapse rates in the two groups were not significantly different. No patient had to be hospitalized. One patient in the control group dropped out. The mean reduction of antipsychotic dose in the individualized dose-reduction group was 42%, however only one patient discontinued drug completely. There were no significant differences in efficacy or safety outcomes. This randomized trial provides evidence, that reduction of antipsychotic medication in chronic stable schizophrenic patients may be feasible. The results need to be confirmed in a larger trial with a longer follow-up period. Electronic supplementary material The online version of this article (10.1007/s00406-020-01109-y) contains supplementary material, which is available to authorized users.

Just as the World Psychiatric Association (WPA) and other national psychiatric societies, the German Association for Psychiatry, Psychotherapy and Psychosomatics (DGPPN) has published a position statement about religiosity and spirituality in psychiatry and psychotherapy, in which it demands patient orientation and spiritual competency in psychiatric professions. Previous research has shown that lack of competency is the major barrier against implementing spiritual care into clinical practice.The aim of this study was to examine spiritual care in psychiatry and psychotherapy. An evaluation of how health professionals in psychiatry gauge the spiritual care competency of their professional group and which variables influence this judgement.A total of 391 psychiatric nursing personnel, 75 psychiatrists, 119 therapists from diverse professions and 62 others, i.e. 647 working in German and Austrian hospitals completed the German version of the spiritual care competency questionnaire (SCCQ).Nursing personnel, older and spiritually more experienced persons gauged the spiritual competency of their own professional group comparatively higher and judged less frequently that they have no responsibility in this field. Nursing personnel reported the lack of suitable rooms as a barrier against implementation of spiritual care more often than other professional groups. Judging the spiritual competency of one's own professional group higher is associated with higher values in the SCCQ factors self-experience and proactive opening up, team spirit, perception and documentation competency.The responsibility of healthcare professions for spiritual care in psychiatry and psychotherapy is still a controversial issue among German-speaking psychiatric professional groups. This is partially due to a lack of competency in this domain.HINTERGRUND: Ebenso wie die World Psychiatric Association (WPA) und andere nationale psychiatrische Fachgesellschaften hat auch die Deutsche Gesellschaft für Psychiatrie und Psychotherapie, Psychosomatik und Nervenheilkunde (DGPPN) ein Positionspapier zu Religiosität und Spiritualität (R/Sp) in Psychiatrie und Psychotherapie veröffentlicht, in dem sie Patientenzentrierung und spirituelle Kompetenz (SpK) der psychiatrischen Berufe fordert. Es ist bekannt, dass Kompetenzmangel das wichtigste Hindernis für die Implementierung von Spiritual Care (SpC) in die klinische Praxis darstellt.Ziel der vorliegenden Studie ist die praxisnahe Untersuchung der SpK in Psychiatrie und Psychotherapie. Wie schätzen psychiatrisch Tätige die SpK ihrer eigenen Berufsgruppe ein und welche Variablen beeinflussen dieses Urteil?Insgesamt 391 psychiatrische Pflegekräfte, 75 Psychiater, 119 Therapeuten verschiedener Professionen und 62 andere (n = 647) aus Krankenhäusern in Deutschland und Österreich füllten den SpC Competency Questionnaire (SCCQ) aus.Pflegekräfte, ältere und spirituell erfahrenere Personen schätzen die SpK der eigenen Berufsgruppe vergleichsweise höher ein und meinen seltener, diesbezüglich nicht zuständig zu sein. Pflegende nennen häufiger als andere Berufsgruppen das Fehlen geeigneter Räumlichkeiten als Hindernis für die Implementierung von SpC. Höhere Einschätzung der SpK der eigenen Berufsgruppe geht mit höheren Werten in den SCCQ-Faktoren „Selbsterfahrung und proaktive Öffnung“, „Team-Spirit“, „Wahrnehmungs‑/Dokumentationskompetenz“ einher.Die Zuständigkeit der Gesundheitsberufe für SpC in Psychiatrie und Psychotherapie wird unter den deutschsprachigen psychiatrischen Berufsgruppen noch kontrovers diskutiert. Dies hängt mit mangelnder Kompetenz in diesem Feld zusammen.

Background The present study aimed at answering three research questions: (a) Does shared decision making (SDM) yield similar effects for patients with involuntary admission or incidents of aggression compared to patients with voluntary admission or without incidents of aggression? (b) Does SDM reduce the number of patients with incidents of aggression and the use of coercive measures? (c) Does the use of coercion have a negative impact on patients’ perceived involvement in decision making? Methods We used data from the cluster-randomized SDM-PLUS trial in which patients with schizophrenia or schizoaffective disorder in 12 acute psychiatric wards of 4 German psychiatric hospitals either received an SDM-intervention or treatment as usual. In addition, data on aggression and coercive measures were retrospectively obtained from patients’ records. Results The analysis included n = 305 inpatients. Patient aggression as well as coercive measures mostly took place in the first days of the inpatient stay and were seldom during the study phase of the SDM-PLUS trial. Patients who had been admitted involuntarily or showed incidents of aggression profited similarly from the intervention with regard to perceived involvement, adherence, and treatment satisfaction compared to patients admitted voluntarily or without incidents of aggression. The intervention showed no effect on patient aggression and coercive measures. Having previously experienced coercive measures did not predict patients’ rating of perceived involvement. Conclusion Further research should focus on SDM-interventions taking place in the very first days of inpatients treatment and potential beneficial long effects of participatory approaches that may not be measurable during the current inpatient stay.

This study sought to evaluate a new stated-preference instrument to prioritize multiple treatment goals among people with recent onset schizophrenia.A draft survey instrument was developed to assess preferences for 13 key treatment goals that were identified based on the literature. The survey incorporates best-worst scaling (BWS), which shows repeated subsets comprising 4 of the 13 goals, and respondents identify which is most important and which is least important to them. Pre-test interviews were conducted in the UK, Italy, and Germany among people aged 18 to 35 diagnosed with schizophrenia within the past 5 years. Specifically, participants completed the instrument online in their native language, followed by a telephone interview to provide feedback on the clarity, relevance, and comprehensiveness of the survey. The interview data were analyzed to assess interpretation and content validity of the survey.Fifteen participants (five per country) provided feedback (mean age = 31; 60% male). Feedback was comparable across countries and confirmed that the key treatment goals assessed were relevant and meaningful. Probing by interviewers ascertained that respondents interpreted the questions appropriately and identified the treatment goals that were most and least important to them. Based on the characterization of the goals, a conceptual model was developed illustrating hypothesized associations among them.The results confirm that the BWS methodology and key treatment goals in this new instrument are appropriate for use in recent onset schizophrenia. These results will help guide measurement of patient-relevant endpoints in future studies.

Das Modell des „shared decision-making“ (SDM, partizipative Entscheidungsfindung) wurde seit den 1990er Jahren fur verschiedenste Bereiche der Medizin propagiert, konnte aber bisher trotz breiten Interesses und positiver Befunde aus klinischen Studien in der psychiatrisch-klinischen Routine nur wenig umgesetzt werden. Das Konzept und dessen Umsetzbarkeit in der Psychiatrie werden im Folgenden hinterfragt und mogliche Grunde fur die bisher schleppende Anwendung erlautert. Anschliesend stellen die Autoren konkrete Strategien zum Einsatz von SDM im psychiatrischen Versorgungsalltag und aktuell dazu laufende klinische Studien zu deren Praktikabilitat und Effektivitat vor. Neben dem allgegenwartigen Argument des Zeitdrucks werden von Psychiatern die Einschrankungen der Fahigkeit der Patienten in der gemeinsamen Entscheidungsfindung sowie die Furcht vor moglicherweise fur den Patienten unvorteilhaften Ergebnissen berichtet. Aber auch eine missverstandene Reduktion des Entscheidungsprozesses auf die blose Informationsweitergabe und das Haften am tradierten paternalistischen Entscheidungsprozess spielen tragende Rollen. Diese Hurden konnten durch Kommunikationstrainings des medizinischen Fachpersonals (Pflegende, Arzte, Psychologen, Soziotherapeuten), den Einsatz von Entscheidungshilfen (in Form von Broschuren oder auch internetbasiert) und die Unterstutzung der patientenseitigen Kommunikation mit den Therapeuten (Trainingskurse und Anleitungen zu Fragestellungen) abgebaut werden und damit der von zahlreichen Leitlinien geforderte patientenzentrierte Therapieansatz weiter fortentwickelt werden.

Background Prescription rates for long-acting injectable (LAI) antipsychotic formulations remain relatively low in Europe despite improved adherence over alternative oral antipsychotic treatments. This apparent under-prescription of LAI antipsychotics may have multiple contributing factors, including negative mental health practitioner attitudes towards the use of LAIs. Methods The Antipsychotic Long acTing injection in schizOphrenia (ALTO) non-interventional study (NIS), conducted across several European countries, utilised a questionnaire that was specifically designed to address physicians’ attitudes and beliefs towards the treatment of schizophrenia with LAI antipsychotics. Exploratory principal component analysis (PCA) of feedback from the questionnaire aimed to identify and characterize the factors that best explained the physicians’ attitudes towards prescription of LAIs. Results Overall, 136/234 solicited physicians returned fully completed questionnaires. Physicians’ mean age was 48.5 years, with mean psychiatric experience of 20.0 years; 69.9% were male, 84.6% held a consultant position, and 91.9% had a clinical specialty in general adult care. Most physicians considered themselves to have a high level of clinical experience with LAI antipsychotics (77.2%), with an increased rate of LAI antipsychotics prescription over the last 5 years (59.6%). Although the majority of physicians (69.9%) declared feeling no difference in stress levels when offering LAI compared to oral antipsychotics, feelings of ‘no/more stress’ versus ‘less stress’ was found to influence prescription patterns. PCA identified six factors which collectively explained 66.1% of the variance in physician feedback. Multivariate analysis identified a positive correlation between physicians willing to accept usage of LAI antipsychotics and the positive attitude of colleagues (co-efficient 3.67; p = 0.016). Conclusions The physician questionnaire in the ALTO study is the first to evaluate the attitudes around LAI antipsychotics across several European countries, on a larger scale. Findings from this study offer an important insight into how physician attitudes can influence the acceptance and usage of LAI antipsychotics to treat patients with schizophrenia.

This report presents the rationale and design of a multi-center clinical trial that examines the efficacy and safety of antipsychotic combination treatment in acutely ill schizophrenia patients compared to antipsychotic monotherapy. Antipsychotic combination treatment is common in clinical practice worldwide, despite clinical guidelines generally not recommending such practice due to lacking evidence for its efficacy and safety. Olanzapine has a related chemical structure and comparable receptor-binding profile as clozapine, which demonstrated superior efficacy in combination studies, but has a more unfavorable side-effect profile compared to olanzapine. Amisulpride and olanzapine have shown promising therapeutic efficacy in meta-analyses in monotherapy for people with schizophrenia. Combining amisulpride and olanzapine, complementary receptor-binding properties may enhance efficacy and possibly reduce (or at least not augment) side effects due to the different receptor profiles and metabolization pathways. Accordingly, we hypothesize that patients treated with amisulpride plus olanzapine show greater improvement on the Positive and Negative Syndrome Scale total score after 8 weeks versus either monotherapy. A randomized, double-blind controlled trial is performed at 16 German centers comparing flexibly dosed monotherapy of oral amisulpride (400-800 mg/day), and olanzapine (10-20 mg/day) and amisulpride-olanzapine co-treatment. Sample size was calculated to be n = 101 per treatment arm, assuming an effect size of 0.500 and a two-sided alpha = 0.025 and beta = 0.90. Recruitment for this trial started in June 2012. Until December 2018, 328 patients have been randomized. Trial conduct has been extended to reach the projected sample size. Publication of the study results is expected in 2019 informing an evidence-based recommendation regarding specific antipsychotic combination treatment.

Patient involvement (shared decision making ) and caregiver involvement (family involvement, etc.) are mostly seen as different aspects of care, and efforts to integrate them are limited. This Open Forum posits that both approaches are critical and that caregiver involvement should always be considered during shared decision making, potentially as an integral component. The authors argue that the two approaches can overlap and work synergistically rather than antagonistically. When caregiver involvement is integrated into shared decision making, caregivers may assume any of a variety of roles and need to develop certain competencies to better engage in decision making.

Background: Dose equivalents of antipsychotics are an important but difficult to define concept, because all methods have weaknesses and strongholds. Methods: We calculated dose equivalents based on defined daily doses (DDDs) presented by the World Health Organisation's Collaborative Center for Drug Statistics Methodology. Doses equivalent to 1 mg olanzapine, 1 mg risperidone, 1 mg haloperidol, and 100 mg chlorpromazine were presented and compared with the results of 3 other methods to define dose equivalence (the "minimum effective dose method," the "classical mean dose method," and an international consensus statement). Results: We presented dose equivalents for 57 first-generation and second-generation antipsychotic drugs, available as oral, parenteral, or depot formulations. Overall, the identified equivalent doses were comparable with those of the other methods, but there were also outliers. Conclusions: The major strength of this method to define dose response is that DDDs are available for most drugs, including old antipsychotics, that they are based on a variety of sources, and that DDDs are an internationally accepted measure. The major limitations are that the information used to estimate DDDS is likely to differ between the drugs. Moreover, this information is not publicly available, so that it cannot be reviewed. The WHO stresses that DDDs are mainly a standardized measure of drug consumption, and their use as a measure of dose equivalence can therefore be misleading. We, therefore, recommend that if alternative, more " scientific" dose equivalence methods are available for a drug they should be preferred to DDDs. Moreover, our summary can be a useful resource for pharmacovigilance studies.

Background: Preclinical studies recently showed that the mineralocorticoid antagonist spironolactone acts also as an antagonist of the NRG1-ERBB4 signaling pathway and improves schizophrenia-like behaviour in Nrg1 transgenic mouse model. As this signaling pathway is critically linked to the pathophysiology of schizophrenia, especially in the context of working-memory dysfunction, spironolactone may be a novel treatment option for patients with schizophrenia targeting cognitive impairments. Aims: To evaluate whether spironolactone added to an ongoing antipsychotic treatment improves cognitive functioning in schizophrenia. Methods: The add-on spironolactone for the treatment of schizophrenia trial (SPIRO-TREAT) is a multicenter randomized, placebo-controlled trial with three arms (spironolactone 100 mg, spironolactone 200 mg and placebo). Schizophrenia patients are treated for three weeks and then followed-up for additional nine weeks. As primary outcome, we investigate changes in working memory before and at the end of the intervention phase. We will randomize 90 patients. Eighty-one patients are intended to reach the primary endpoint measure at the end of the three-week intervention period. Secondary endpoints include other measures of cognition, psychopathology, safety measures and biological measures. Conclusions: SPIRO-TREAT is the first study evaluating the efficacy of the mineralocorticoid receptor antagonist spironolactone to improve cognitive impairments in schizophrenia patients targeting the NRG1-ERBB4 signaling pathway. With SPIRO-TREAT, we intend to investigate a novel treatment option for cognitive impairments in schizophrenia that goes beyond the established concepts of interfering with dopaminergic neurotransmission as key pathway in schizophrenia treatment. Clinical trial registration: International Clinical Trials Registry Platform: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-001968-35-DE Keywords: Schizophrenia, Cognitive impairment, Spironolactone, NRG1-ERBB4, Drug repositioning, Drug repurposing

Background:The Antipsychotic Long-acTing injection in schizOphrenia (ALTO) study was a non-interventional study across several European countries examining prescription of long-acting injectable (LAI) antipsychotics to identify sociodemographic and clinical characteristics of patients receiving and physicians prescribing LAIs. ALTO was also the first large-scale study in Europe to report on the use of both first- or second-generation antipsychotic (FGA- or SGA-) LAIs.Methods:Patients with schizophrenia receiving a FGA- or SGA-LAI were enrolled between June 2013 and July 2014 and categorized as incident or prevalent users. Assessments included measures of disease severity, functioning, insight, well-being, attitudes towards antipsychotics, and quality of life.Results:For the 572 patients, disease severity was generally mild-to-moderate and the majority were unemployed and/or socially withdrawn. 331/572 were prevalent LAI antipsychotic users; of whom 209 were prescribed FGA-LAI. Paliperidone was the most commonly prescribed SGA-LAI (56% of incident users, 21% of prevalent users). 337/572 (58.9%) were considered at risk of non-adherence. Prevalent LAI users had a tendency towards better insight levels (PANSS G12 item). Incident FGA-LAI users had more severe disease, poorer global functioning, lower quality of life, higher rates of non-adherence, and were more likely to have physician-reported lack of insight.Conclusions:These results indicate a lower pattern of FGA-LAI usage, reserved by prescribers for seemingly more difficult-to-treat patients and those least likely to adhere to oral medication.

Shared decision making has found its way into mental health care to a limited extent only, and especially "challenging" patients do not benefit from this approach. The authors describe barriers to shared decision making among mental health professionals and among patients. They propose an integrative approach-SDM-PLUS-that fosters shared decision making in mental health settings. SDM-PLUS empowers both patients and mental health care providers. Patients are empowered to become more active and self-confident and to acquire greater skills in regard to health literacy and communication. Providers are trained in analyzing decisional situations and are empowered to use a wider array of communication strategies to optimize patient participation.

The use of long-acting injectable antipsychotics (LAIs) in schizophrenia is usually restricted to patients in long-term treatment, who prefer them to oral antipsychotics, and to patients with multiple relapses who have a history of non-adherence. However, preliminary evidence from patients in the early phases of the disease suggest that second generation LAIs may be superior to second generation oral medications with regard to the control of negative symptoms and psychosocial functioning. Moreover, several studies have found that psychiatrists are generally reluctant to prescribe LAI antipsychotics and under-estimate their acceptability by patients. Key elements to take into account when offering a LAI in the early course of schizophrenia should include their potential superiority in allowing early detection of non-adherence and in reducing the number of rehospitalisations and relapses.

Background The concept of dose equivalence of depot medication is important for many scientific and clinical purposes. Methods A systematic literature search on four second-generation antipsychotics available as long-acting injectable drugs and haloperidol was conducted. We used the minimum effective dose method which is based on randomized fixed dose studies where the smallest dose which was significantly more efficacious than placebo in the primary outcome was declared as minimum effective dose. We calculated equivalent doses from acute phase studies but we also reported the minimum effective doses found in relapse prevention studies. Results The acute phase minimum effective doses/olanzapine equivalents were: aripiprazole lauroxil 441 mg (300 mg aripiprazole)/4wks/0.71; aripiprazole 400 mg/4 weeks/0.95 (aripiprazole maintena); paliperidone palmitate 25 mg/4 weeks/0,06; risperidone 25 mg/2 weeks/0,12; RBP-7000 90 mg/4 weeks/0,21; olanzapine 210 mg/2 weeks/1. Conclusions The minimum effective dose method is an operationalized and evidence-based approach for determining antipsychotic dose equivalence which can also be applied to long-acting injectable formulations. Doses may not have been chosen low enough to find the truly minimum effective dose. Comparisons with other methods will be necessary to come to ultimate conclusions.

Treatment with long-acting depot antipsychotics may yield beneficial effects with regard to long-term adherence and long term outcomes in patients with schizophrenia. However, the implementation of depot treatment is rather low in many settings. Research on this issue helped identifying various potential reasons for this pattern including patient refusal and negative attitudes of psychiatrists. Nevertheless no definite conclusion exists as to what actually hinders the wider implementation of depot treatment. To date there are no studies that surveyed this issue with regard to concrete patients and from both perspectives, of the psychiatrists and the related patients. In the present analysis we therefore analyzed psychiatrists׳ and patients׳ behavior regarding depot prescription in N=213 individual doctor-inpatient-dyads in German psychiatric hospitals. A high number of patients (30%) were actually prescribed depot at discharge, even more were informed about the possibility of depot treatment by their psychiatrists (47%). Moreover, 50% of the surveyed patients were generally open toward receiving depot antipsychotics. However, for the high number of patients not receiving depot (70%) the psychiatrists׳ arguments against depot were often implausible and therefore many more patients might be suitable for receiving depot treatment. Psychiatrists׳ hesitation to discuss and implement depot might also be founded in concerns regarding patients׳ acceptance of depot medication. Here doctors should be empowered by teaching communication strategies that may help to convince patients accept treatment.

For many psychiatric conditions outcomes of standard care still fall short of outcomes that are possible according to research literature. One of the major reasons is patient׳s non-adherence to long-term medication. We performed a mirror image interventional study involving patients suffering from affective (N=219) or psychotic disorders (N=210) who participated in an integrated care program focusing on treatment adherence. The main outcome variable was the number of inpatients days during the integrated care program compared to the time before the program. The integrated care project studied showed a drop of inpatient days of approx. 75% within the 18-months observation period for both groups. In the affective (psychotic) sample inpatients days dropped from M=47.1 days (M=62.2 days) in the 18 months before the program to M=10.8 days (M=15.3 days) during the adherence program. Patients with affective disorders additionally profited with regard to symptom reduction, quality of life and self-reported adherence. Thus, a complex intervention addressing frequent weaknesses of routine psychiatric outpatient care and focussing on adherence and linking up outpatient services is effective with regard to the reduction of inpatient days for patients with affective and patients with schizophrenic disorders.