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ZUSAMMENFASSUNGDie stationsäquivalente Behandlung (StäB) ist eine besondere Form des international anerkannten und evidenzbasierten Home-Treatment. Als komplexe Intervention erfordert StäB im deutschen Kontext eine Evaluation auf unterschiedlichen Ebenen. Die quasi-experimentelle „AKtiV-Studie“ mit Propensity-Score-gematchter Kontrollgruppe entspricht dieser Forderung. Sie hat eine Laufzeit von 36 Monaten und wird vom Innovationsfonds des Gemeinsamen Bundesausschuss gefördert. In diesem Zeitraum werden neben der Untersuchung klassisch klinischer Endpunkte wie der stationären Wiederaufnahmerate, der Psychopathologie und Recovery-orientierten auch Fragen hinsichtlich der geeigneten Zielpopulationen, Implementierungsbedingungen, Behandlungsprozessen und Wirkfaktoren beantwortet. Dabei werden sowohl die Perspektiven von Patienten, Angehörigen und Mitarbeitenden als auch die Standpunkte und Erfahrungen von Akteuren aus Politik und Selbstverwaltung eruiert. Damit kann erwartet werden, dass die Studienergebnisse für ein breites Publikum interessant sein und zur praxiswirksamen Weiterentwicklung des StäB-Modells beitragen können. Im vorliegenden Artikel wird das Mixed-Methods-Design der AktiV-Studie vorgestellt und diskutiert.

Versorgungsforschung im Feld der seelischen Gesundheit ist von zunehmender Bedeutung. Angesichts dieser Entwicklung hat die im Oktober 2017 gegrundete DNVF Fachgruppe „Seelische Gesundheit“ ein Diskussionspapier verfasst, welches zentrale Besonderheiten, Herausforderungen und Ziele der Versorgungsforschung im Bereich der seelischen Gesundheit zusammenfasst. Im Einzelnen werden forschungsrelevante Besonderheiten des Versorgungsfeldes, pragmatische Probleme bei der Forschungsorganisation, ethische Herausforderungen und fur dieses Feld besondere Themenstellungen vorgestellt und diskutiert.

Ziel Seit 2013 haben sich in Deutschland 22 psychiatrische Modellvorhaben nach § 64b SGB V (MV) gebildet, die auf Basis eines globalen Behandlungsbudgets (GBB) eine flexible und settingübergreifende Versorgung bieten. Als Teilprojekt der „PsychCare“-Studie werden die Anreize, Voraussetzungen und Herausforderungen von GBB untersucht. Methode Es wurden Interviews und Fokusgruppen mit Mitarbeitenden (n = 29) aus Controlling und Management an 7 MV sowie 3 Krankenkassen (KK) geführt und qualitativ ausgewertet. Ergebnisse Zentral für die Einführung von GBB sind die Kooperation sowie gemeinsame Steuerungsziele zwischen Kliniken und KK. Als herausfordernd werden u. a. die settingübergreifende Leistungsdokumentation und -steuerung sowie der parallele Betrieb von Modell- und Regelversorgung erlebt. Schlussfolgerung GBB stellen einen starken Antrieb zur organisationalen Transformation für eine zukunftsweisende psychiatrische Versorgung dar. Bei der Weiterentwicklung von GBB sollte der bislang fehlende Kontrahierungszwang für alle Krankenkassen berücksichtigt werden.

Die Definition von Pflegepersonaluntergrenzen und die Ausgliederung des Pflegebudgets aus dem DRG(„diagnosis related groups“)-System soll die Strukturqualitat und Vergutung der Pflege in der Somatik verbessern. In der Psychiatrie und Psychosomatik wurden zwar verbindliche Personalvorgaben definiert, nicht geregelt wurde hingegen, wie dieses (Pflege‑)Personal hinreichend finanziert wird. Untersucht werden die Zusammensetzung der Pflegepersonalkosten in psychiatrischen und psychosomatischen Kliniken sowie mogliche Auswirkungen der Ausgliederung von Pflegekosten auf das Pauschalierende Entgeltsystem Psychiatrie und Psychosomatik (PEPP). Grundlage der Analyse sind die vom Institut fur das Entgeltsystem im Krankenhaus (InEK) jahrlich veroffentlichten, aggregierten Behandlungskosten je Tag der an der InEK-Kalkulation teilnehmenden Kliniken (Datenjahr: 2018). Die Pflegekosten stellen in der stationaren Psychiatrie und Psychosomatik den grosten Kostenfaktor dar. Der Anteil der Pflege an der Varianz der Kosten ubersteigt sogar ihren Anteil an den Gesamtkosten. Nach rechnerischem Herauslosen der Pflege unterscheiden sich die Tageskosten sowohl innerhalb der Basis-PEPP als auch der Strukturkategorien Erwachsenen‑, Kinder- und Jugendpsychiatrie und Psychosomatik nur noch geringfugig. Die Sicherung einer auskommlichen Finanzierung der Pflege wirft die Debatte um die Weiterentwicklung der psychiatrischen Vergutung erneut auf. Es stellt sich die Frage, ob der mit Anwendung des PEPP-Systems verbundene Aufwand seinem Nutzen als Instrument zur Budgetermittlung gerecht wird, wenn Kernfunktionen wie die Kostentrennung nur begrenzt gegeben sind. Es sollten daher alternative Ansatze zur Budgetermittlung gepruft werden, deren Kosten und Nutzen in einem besseren Verhaltnis stehen.

Zusammenfassung Ziel Untersucht werden die Bedingungen und Hürden der Einführung von Stationsäquivalenter Behandlung nach § 115d SGB V (StäB). Methode Qualitative Analyse von Interviews und Fokusgruppen mit Mitarbeitenden (n = 43) an 11 psychiatrischen Kliniken in Berlin/Brandenburg. Ergebnisse Auf Systemebene wird die Implementierung u. a. durch eine inadäquate Leistungsdefinition, fehlende Vorgaben auf Landesebene, Personalmangel und MDK-Prüfungen erschwert. Dies führt bei Kliniken zu zurückhaltender Umsetzung mit teilweise unzureichender personeller Ausstattung der StäB-Teams. Weitere Barrieren betreffen das Fehlen mobiler Lösungen zur Dokumentation und Teamkommunikation. Auf Ebene der Mitarbeitenden wirken sich ein Mangel an Information und Kooperation sowie unklare Aufgaben und Rollen hinderlich aus. Schlussfolgerungen Für eine bedürfnisorientierte, flexible und flächendeckende Einführung von StäB sind Nachbesserungen an den Rahmenbedingungen sowie weitere Forschung zur Wirksamkeit und Implementierung notwendig.

Severe weight gain induced by psychotropics is a known problem in psychiatry. Various drugs from different classes may lead to weight gain that may further lead to potentially life-shortening diseases, such as diabetes or cardiovascular disease. A total of 344 cases of severe weight gain (>10% of body weight) have been documented by the drug safety in psychiatry program AMSP between 2001 and 2016. Patients gained 12.7 ± 5.5 kg weight within 12±15 weeks. This equals a Body Mass Index (BMI) gain of 4.4 ± 1.9 kg/m² to a final BMI of 28.8 ± 5.5 kg/m². In addition, 142 retrospective reports documented at admission have been analyzed. Within one year these patients gained 6.4 ± 4.0 kg/m² to a final BMI of 31.9 kg/m². The weight gain was extreme in some cases. For example, 35% of the patients gained more than 20 kg. On average the patients reached overweight or even adiposity. Only 27% of the patients could loose some weight at the end of their stay. This emphasizes the relevance of this long-term problem for the patients’ health. Mostly second generation antipsychotics, and therein olanzapine, as well as antidepressants and anticonvulsants have been imputed. Severe weight gain is a slow process and it is rarely documented as adverse drug reaction under real-life conditions compared to the high percentage of patients with weight gain in clinical studies. It might often remain unnoticed due to shorter stationary treatment and changing treatment settings.

Background Impaired subjective well-being in schizophrenia patients treated with antipsychotics has often been linked inter alia to the antidopaminergic effects of medication. Thus, it is important to capture the association between striatal dopamine D2 receptor occupancy (D2-RO) and global subjective well-being. We examined this association using data from our multicenter, randomized, double-blind Neuroleptic Strategy Study (NeSSy). Methods An innovative double randomization process was used for allocation of patients to the specific treatment groups. Plasma drug concentrations were measured after 6 and 24 weeks of treatment to obtain the estimated D2-RO (eD2-RO) relative to literature values. We made an exploratory analysis of associations between eD2-RO and subjective well-being scores. One hundred two blood samples from 69 patients were available for the analysis. Because of the lack of a satisfactory occupancy model for quetiapine, only haloperidol, flupentixol, and olanzapine treatment groups were pooled, whereas aripiprazole data were analyzed separately, because of its partial agonistic properties. Results In the pooled antagonist group, eD2-RO correlated negatively with the summarized well-being score. In a more detailed analysis, this association could be confirmed for all first-generation antipsychotic-treated patients, but not for the separate second-generation antipsychotic groups. In the aripiprazole group, higher eD2-RO was associated with impaired physical well-being, but had no association with mental well-being. Conclusions Our results suggest that high plasma levels and consequently high occupancy at D2 receptors are disadvantageous for subjective well-being, as distinct from the objective extrapyramidal side effects. To minimize patients' malaise, which disfavors adherence, implementation of therapeutic drug monitoring in the clinical routine may be useful.

Zusammenfassung Ziel Bundesweit gibt es 19 Modellvorhaben nach §64b SGB V (MV), die eine settingübergreifende und flexible psychiatrische Behandlung anbieten. In Schleswig-Holstein (SH) haben sich fünf dieser Modelle gebildet. In einer vergleichenden Analyse wird die Implementierung der MV in SH gegenüber dem Bundesgebiet untersucht. Methodik Standardisierte Befragung von 383 Patienten aus sieben Kliniken, davon drei aus SH, zur Beurteilung der Modellversorgung. Es wurden Struktur-, Leistungs- sowie Daten zum Implementierungsstand von MV in SH und den übrigen Bundesländern analysiert. Ergebnisse MV in SH weisen eine stärkere Ausprägung modellspezifischer Merkmale und einen höheren Implementierungsgrad gegenüber der Vergleichsgruppe auf. Sie befinden sich in öffentlicher Trägerschaft und sind mit allen Krankenkassen verhandelt. Patienten dieser MV werden häufiger ambulant oder aufsuchend behandelt, verfügen über mehr Erfahrung mit spezifischen Aspekten der MV und bewerten diese besser. Schlussfolgerung Die Implementierung der MV in SH kann als besonders erfolgreich angesehen werden. Unter anderem scheint die Unterstützung der Landespolitik eine entscheidende Triebkraft hierfür zu sein.

Zusammenfassung Ziel der Studie Psychopharmaka werden in Pflegeheimen oft verordnet und stellen zusammen mit allgemeiner Polypharmazie ein Risiko für unerwünschte Wirkungen und Arzneimittelwechselwirkungen dar. Methodik Medikationsdaten (n = 398) wurden erhoben und Leitfadeninterviews bzw. Fokusgruppen durchgeführt. Ergebnisse Etwa 70 % der Bewohner bekommen Psychopharmaka. Einfluss haben Arbeitsbelastung der Pflegenden, soziodemografische Entwicklung und Facharztmangel. Schlussfolgerung Es muss ein Bewusstsein für Risiken durch Psychopharmaka geschaffen und gleichzeitig deren Reduktion angestrebt werden.

Objective: Priapism is a rare adverse effect of several psychotropics. Both, typical and atypical antipsychotics, as well as trazodone are known to cause priapism. The mechanism is still not fully understood, however, the most common assumption is that priapism occurs due to the α-adrenergic blocking effects of the drugs. Methods: Here we present from the AMSP database 19 cases of priapism being likely caused by a variety of psychotropics. We further reviewed case reports in order to find similarities and to identify risk factors. Results: Several patterns emerged: common was the introduction of a specific drug to a patient resulting into the immediate development of priapism, as well as a change in drug plasma concentration due to a change of drug dosage or due to comedication with certain SSRIs. Conclusion: However, priapism can occur at nearly any age and with any dose. Clinicians must be aware of the risk and reports of early signs, such as prolonged erections, should be taken seriously.

BackgroundOver the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms ofInpatient Equivalent Home Treatment(IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user’s home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity.Methods/designThe presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders’ experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical ‘twins’ receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective.DiscussionBy integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention.Trial registrationTrial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020,https://www.drks.de/drks_web/setLocale_EN.do; 2) ClinicalTrials.gov, Identifier:NCT0474550. Registered February 9th 2021.

Background: Internationally, there is a broad spectrum of outreach and integrative care models, whereas acute psychiatric treatment in Germany is still mostly provided in inpatient settings. To overcome this, a new legal framework (§64b Social Code V) has been introduced, promoting „Flexible and Integrative Treatment“ (FIT64b) models, based on a “Global Treatment Budget” (GTB) financing approach. Although each of the recent 23 adopters has implemented the framework according to local needs and concepts, prior research could identify FIT64b specific components. Based on this, our paper aims to examine the implementation process and underpinning change mechanisms of GTB-based FIT64b models from a staff, service user and caregiver perspective. Method: 31 focus groups and 15 semi-structured interviews were conducted with hospital staff (n = 138), service users (n = 63) and caregivers (n = 35) in 10 psychiatric hospitals implementing FIT64b. Using qualitative analysis, we identified 5 core themes describing the implementation process, which were theoretically modelled into a logical diagram. The core mechanisms of change were thus identified across themes. Additional structural and semi-quantitative performance data was collected from all study departments. Results: The qualitative analysis showed that the shift from a daily- and performance-based payment to a lump-sum GTB and the shift of resources from in- to outpatient settings were of crucial importance for the process of change. Saved budget shares could be reinvested to integrate in-, out- and day-patient units and to set up outreach home care. Clinicians reported feeling relieved by the increase of treatment options. They also emphasized a stronger relationship with and a better understanding of service users and a simplification of bureaucracy. Finally, service users and caregivers experienced higher need-adaptedness of treatment, a feeling of deeper understanding and safety, and the possibility to maintain everyday life during treatment. Finally, two FIT64b implementation prototypes were classified according to the semi-quantitative performance data. Conclusion: Based on the results, we developed 3 core mechanisms of change of FIT64b models: 1. Need-adaptedness and flexibility; 2. Continuity of care; 3. Maintaining everyday life. Our findings outline and emphasize the potentials a GTB approach may have for improving psychiatric hospital services.

Zusammenfassung. Hintergrund und Fragestellung: Seit 2013 sind in Deutschland die Möglichkeiten für eine integrative Behandlungsform gemäß § 64b SGB (Sozialgesetzbuch) V erweitert worden. Diese sogenannte psychiatrische Modellversorgung (MV) ist in den letzten Jahren sowohl an einzelnen Kliniken der Erwachsenen- als auch der Kinder- und Jugendpsychiatrie und -psychotherapie (KJPP) eingeführt worden. Ziel der MV ist es, eine ambulante, individualisierte und kontinuierliche Behandlung anzubieten. In der vorliegenden Arbeit werden die Erfahrungen der Stakeholder mit dieser innovativen Behandlungsform untersucht. Methodik: An zwei kinder- und jugendpsychiatrischen Kliniken der MV wurden Fokusgruppen durchgeführt, an denen Mitarbeitende, Patientinnen und Patienten sowie Eltern (N = 36) teilnahmen. Es folgte eine qualitativ-inhaltsanalytische Auswertung. Ergebnisse: Aus Sicht aller Akteurinnen und Akteure bildet die ambulante Akut Behandlung (AAB) einen zentralen Modellbestandteil, die eine Behandlung von Patientinnen und Patienten mit akuten Beschwerden im Vorfeld, als Ersatz oder im Nachgang einer (teil)stationären Behandlung ermöglicht. Die Flexibilisierung der Behandlung und eine größere Behandlungs- und Behandlerkontinuität wurden als weitere Vorteile der MV genannt. Schließlich gelingt der Einbezug von Sorgeberechtigten im Rahmen der MV leichter, was für diese Akteursgruppe auch einige Herausforderungen mit sich bringt. Schlussfolgerungen: Die Einführung psychiatrischer MV in der KJPP hat komplexe Auswirkungen auf die Behandlungsabläufe und das Erleben aller beteiligten Akteurinnen und Akteure und wird von diesen als bedürfnisorientierte Ausweitung therapeutischer Unterstützungsmöglichkeiten erlebt.

Background Flexible and integrative treatment (FIT) models are rather novel in German mental health care. This study aimed at identifying and evaluating empirically based, practicable, and quantifiable program components that describe the specific treatment structures and processes of German FIT models. Methods A multi-step, iterative research process, based on Grounded Theory Methodology (GTM), was used to identify and operationalise components. A complex algorithm and expert-interviews were applied to quantify the relative weight of each component and to develop a sum score. Face and content validity were examined and internal consistency was tested by Cronbach’s α coefficient. Results Ten of eleven FIT components could be operationalised, quantified and united in the total score. All operationalised components showed sufficient face and content validity and eight components had a good reliability. Conclusions The components are a first step in the process of operationally defining German FIT models. They considerably overlap with various critical ingredients of international FIT models and may serve as a theoretical basis for constructing fidelity tools and research guides to enable process and outcome evaluation of German FIT models.

Bisher fehlte ein theoretisches Modell zur Auswertung der flexiblen und integrativen Versorgung nach § 64b Sozialgesetzbuch (SGB) V. Gemas der Grounded-Theory-Methodologie wurde ein rekursiver Prozess aus Datenerhebung und -analyse durchgefuhrt. Es wurden 11 fur die Modellversorgung spezifische Merkmale identifiziert, die sich als stabil, praktikabel und an die Literatur anschlussfahig erwiesen. Diese Merkmale eignen sich zur Implementierung, Qualitatsentwicklung und Evaluation von Projekten der Modellversorgung nach § 64b SGB V.

Over the last decades, many high-income countries have successfully implemented assertive outreach mental health services for acute care. Despite evidence that these services entail several benefits for service users, Germany has lagged behind and has been slow in implementing outreach services. In 2018, a new law enabled national mental health care providers to implement team-based crisis intervention services on a regular basis, allowing for different forms of Inpatient Equivalent Home Treatment (IEHT). IEHT is similar to the internationally known Home Treatment or Crisis Resolution Teams. It provides acute psychiatric treatment at the user’s home, similar to inpatient hospital treatment in terms of content, flexibility, and complexity. The presented naturalistic, quasi-experimental cohort study will evaluate IEHT in ten hospitals running IEHT services in different German regions. Within a multi-method research approach, it will evaluate stakeholders’ experiences of care, service use, efficacy, costs, treatment processes and implementation processes of IEHT from different perspectives. Quantitative surveys will be used to recruit 360 service users. Subsequently, 180 service users receiving IEHT will be compared with 180 matched statistical ‘twins’ receiving standard inpatient treatment. Assessments will take place at baseline as well as after 6 and 12 months. The primary outcome is the hospital re-admission rate within 12 months. Secondary outcomes include the combined readmission rate, total number of inpatient hospital days, treatment discontinuation rate, quality of life, psycho-social functioning, job integration, recovery, satisfaction with care, shared decision-making, and treatment costs. Additionally, the study will assess the burden of care and satisfaction with care among relatives or informal caregivers. A collaborative research team made up of researchers with and without lived experience of mental distress will conduct qualitative investigations with service users, caregivers and IEHT staff teams to explore critical ingredients and interactions between implementation processes, treatment processes, and outcomes from a stakeholder perspective. By integrating outcome, process and implementation research as well as different stakeholder perspectives and experiences in one study, this trial captures the various facets of IEHT as a special form of home treatment. Therefore, it allows for an adequate, comprehensive evaluation on different levels of this complex intervention. Trial registrations: 1) German Clinical Trials Register (DRKS), DRKS000224769. Registered December 3rd 2020, https://www.drks.de/drks_web/setLocale_EN.do ; 2) ClinicalTrials.gov, Identifier: NCT0474550 . Registered February 9th 2021.

Adjustment disorder is a temporary change in behaviour or emotion as a reaction to a stress factor. Therapy consists of psychotherapy, and pharmacotherapy can be advised. However, data on the real-life pharmacological treatment are sparse. Prescription data for 4.235 psychiatric inpatients diagnosed with adjustment disorder in the time period 2000-2016 were analysed. The data were obtained from the Drug Safety Programme in Psychiatry (AMSP). Data were collected on two reference days per year; prescription patterns and changes over time were analysed. Of all patients, 81.2% received some type of psychotropic drug. Mostly antidepressants (59.8%), antipsychotics (35.5%), and tranquilisers (22.6%) were prescribed. Prescription rates for antidepressants decreased slightly over the years, while rates for antipsychotics increased, especially for atypical antipsychotics. It is important to note that the diagnosis "adjustment disorder" is most likely a working diagnosis that is used for patients in immediate need of psychiatric aid. Overall, pharmacotherapy for inpatients with this diagnosis is mostly symptom-oriented and focuses on depressive moods, agitation and anxiety. Therapy regimes changed over time and show an increased use of atypical antipsychotics with sedative properties. However, for most of the medication, there are neither evidence-based studies nor guidelines, and drugs might be contraindicated in some cases.

Contrary to the practice in some countries, access to flexible and integrated forms of psychiatric care (FIT models) is limited in Germany. Several legislations have been introduced to improve this situation, notably the recent §64b (flexible and integrative treatment model; FIT64b) of the German Social Code, which allows for a capitation-based accounting of fees for services. The aim of this study was to explore the effects of FIT64b implementation on various stakeholders (patients, informal caregivers and staff) in 12 psychiatric hospital departments across Germany. Structural as well as quantitative and qualitative data are included, with integration of different methodological approaches. In all departments, the implementation of the new accounting system resulted into a relatively stable set of structural and processual changes where rigid forms of mainly inpatient care shifted to more flexible and integrated types of outpatient and outreach treatments. These changes were more likely to be perceived by patients and staff, and likewise received better evaluations, in those departments showing higher level or longer duration of implementation. Patients' evaluations, furthermore, were largely influenced by the advent of continuous forms of care, better accessibility, and by their degree of autonomy in steering of their services.

Cognitive impairment represents a core feature of schizophrenia. Uncertainty about demonstrable benefits of available antipsychotics on cognition remains an important clinical question relevant to patients’ quality of life. The aim of our multi-center, randomized, double-blind “Neuroleptic Strategy Study” (NeSSy) was to compare the effectiveness of selected antipsychotics, conventionally classified as second- (SGAs) (haloperidol, flupentixol) and first generation antipsychotics (FGAs) (aripiprazole, olanzapine, quetiapine), on quality of life in schizophrenia. The effects on cognitive deficits represented a secondary outcome. We used an innovative double randomization for assignment of treatment group, and followed the patients with a neurocognitive test-battery upon six and 24 weeks of treatment. Psychopathology and quality of life were assessed using CGI, PANSS and SF-36. Assessment of cognitive performance was conducted in 114 of the 136 randomized patients. The SGA group (N = 62) showed beneficial effects of small to moderate effect size on cognition during the initial six weeks of treatment (executive functions, verbal fluency) and at 24 weeks (executive functions, working memory). In contrast, the FGA group (N = 52) showed moderately improved executive function, but a decline in verbal fluency at six weeks, with significant declines of moderate to large effect size in executive function, verbal learning and memory, and verbal fluency at 24 weeks. Our study indicates that SGAs present an advantage over FGAs regarding cognitive function during a medium-term treatment for schizophrenia. The results further emphasize a distinction between progression to detrimental effects of FGAs with prolonged treatment in contrast to more persistent cognitive benefits with SGA treatment.

Neuroleptic malignant syndrome (NMS) is a rare, but severe adverse drug reaction of drugs with anti-dopaminergic properties. The main symptoms are fever and rigor. In addition, other symptoms such as creatine kinase elevation, alteration of consciousness and various neurological symptoms may occur. A total of 52 NMS cases have been documented in the drug safety program 'Arzneimittelsicherheit in der Psychiatrie' from 1993 to 2015. We calculated incidences and analyzed imputed substances and additional risk factors to study the impact of changing therapy regimes. The overall incidence was 0.16‰. High-potency first-generation antipsychotics (FGAs) had the highest incidences, e.g. flupentixol with 0.61‰. Second-generation antipsychotics (SGAs) had lower incidences. Low-potency FGAs had very low incidences, comparable to SGAs, but in contrast to SGAs, had not been imputed alone in any case of NMS. Preexisting organic pathologies of the central nervous system, lithium treatment, infection/exsiccosis and the withdrawal of medication with anticholinergic properties or alcohol were found to be additional risk factors. With the increasing use of SGAs, one should always be aware of the risk of NMS. Better suited diagnostic criteria for 'atypical NMS' would lead to a better understanding and, therefore, to improved treatment possibilities.

Ziel: Untersucht wurden Faktoren, die das Einschreibeverhalten von Patienten im Rahmen eines Projekts der integrierten Versorgung beeinflussen. Methode: Die Einschreiberaten wurden hinsichtlich Geschlecht und Hauptdiagnose analysiert. Ergebnisse: Die Einschreiberate betrug 59,3 %. Die Diagnose konnte 24,1 % der Variation des Einschreibeverhaltens aufklaren, das Geschlecht beeinflusste dieses nicht signifikant. Die hochste Quote zeigten Patienten mit affektiven Storungen, wohingegen Patienten mit einer F2-Diagnose sich nur zu 34,6 % einschrieben. Schlussfolgerungen: Ein Modell mit Einschreibenotwendigkeit ist fur die Psychiatrie nur bedingt geeignet.

This pilot study aimed to evaluate and examine an instrument that integrates relevant aspects of cross-sectoral (in- and outpatients) mental health care, is simply to use and shows satisfactory psychometric properties. The development of the scale comprised literature research, held 14 focus groups and 12 interviews with patients and health care providers, item-pool generation, content validation by a scientific expert panel, and face validation by 90 patients. The preliminary scale was tested on 385 patients across seven German hospitals with cross-sectoral mental health care (CSMHC) as part of their treatment program. Psychometric properties of the scale were evaluated using genuine and transformed data scoring. To check reliability and postdictive validity of the scale, Cronbach’s alpha coefficient and multivariable linear regression were used. This development process led to the development of an 18-item scale called the “Scale for Evaluation of Psychiatric Integrative and Continuous Care (SEPICC)” with a two-point and five-point response options. The scale consists of two sections. The first section assesses the presence or absence of patients’ experiences with various CSMHC’ relevant components such as home treatment, flexibility of treatments’ switching, case management, continuity of care, cross-sectoral therapeutic groups, and multi-disciplinary teams. The second section evaluates the patients’ opinions about these relevant components. Using raw and transformed scoring resulted into comparable results. However, data distribution using transformed scoring showed a smaller deviation from normality. For the overall scale, the Cronbach’s alpha coefficient was 0.82. Self reported experiences with relevant components of the CSMHC were positively associated with the patients approval of these components. In conclusion, the new scale provides a good starting point for further validation. It can be used as a tool to evaluate CSMHC. Methodologically, using transformed data scoring appeared to be preferable because of a smaller deviation from normality and a higher reliability measured by Cronbach’s alpha.

Background: The ‘gold standard’ for clinical studies is a randomised controlled trial usually comparing specific treatments. If the scientific study expands to strategy comparison with each strategy including various treatments, the research problems are increasingly complicated. The strategy debate in the psychiatric community is the starting point for the development of our new design. It is widely accepted that second-generation antipsychotics are the therapy of choice in the treatment of schizophrenia. However, their general superiority over first-generation antipsychotics could not be demonstrated in recent randomised controlled trials. Furthermore, we are becoming increasingly aware that the experimental conditions of randomised controlled trials, as in the European First Episode Schizophrenia Trial and Clinical Antipsychotic Trials of Intervention Effectiveness Phase 1 studies, may be inappropriate for psychiatric treatments. The high heterogeneity in the patient population produces discrepancies between daily clinical perception and randomised controlled trials results. The patient-oriented approach in the Cost Utility of the Latest Antipsychotic drugs in Schizophrenia Study reflects everyday clinical practice. The results, however, are highly dependent on the physicians’ preferences. The goal of the design described here is to take an intermediate path between randomised controlled trials and clinical studies such as Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study, combining the advantages of both study types. Methods: The idea is to randomise two treatment pairs each consisting of one first-generation antipsychotic and one second-generation antipsychotic in a first step and subsequently, to involve the investigators in deciding for a pair most appropriate to the patients’ needs and then to randomise the allocation to one drug (first-generation antipsychotic or second-generation antipsychotic) of that chosen pair. This idea was first implemented in the clinical trial, the Neuroleptic Strategy Study, with a randomised design comparing efficacy and safety of two different strategies: either to use first-generation antipsychotics (haloperidol and flupentixol) or second-generation antipsychotics (olanzapine, aripiprazole and quetiapine) in patients suffering from schizophrenia. Results: In the course of the Neuroleptic Strategy Study, feasibility of this design was demonstrated. All aspects of the new design were implemented: randomisation process, documentation of responses from investigators as well as patients and drug logistic experience. In implementing the design, furthermore, we could investigate its theoretical properties. The physicians’ preferences for specific drugs used for the respective patients were analysed. Conclusion: The idea of patient-oriented randomisation can be generalised. In light of the heterogeneity and complexity of patient–drug interaction, this design should prove particularly useful.

Aims: This study aims to investigate sleep quality and the subjective dream experience in alcohol-dependent patients during withdrawal and abstinence compared with healthy controls. Methods: Thirty-seven patients with alcohol dependency and 35 healthy control subjects were asked to fill in several questionnaires and to give information about their subjective sleep and dream experiences. Twelve patients participated in a follow-up interview 4 weeks later. Results: Sleep quality is impaired in alcohol-dependent patients during detoxication, and the subjective dream experience is more negatively toned compared with healthy controls. Both sleep quality and dream experience improves slightly after 4 weeks of abstinence. Patients with alcohol dependency during withdrawal and abstinence dream significantly more often about alcohol. However, none of the abstinent alcohol-dependent patients dreamt about alcohol during withdrawal. Conclusions: This study shows that the subjective sleep and dream quality is strongly impaired in patients with alcohol dependency. Differences in the dream experience between alcohol-dependent patients and healthy controls are in accordance with the continuity hypotheses of dreaming. The hypothesis of dreaming about alcohol as a compensatory effect, however, could not be confirmed.

Summary Background Whether or not second-generation antipsychotics (SGAs) represent an advantage over first-generation antipsychotics (FGAs) in the treatment of schizophrenia is not certain. Effectiveness studies published in the past 10 years have not unequivocally confirmed the superiority of SGAs over FGAs. We aimed to compare quality of life in patients with schizophrenia on an FGA strategy with those on an SGA strategy. Methods In the multicentre, randomised, double-blind Neuroleptic Strategy Study (NeSSy), we recruited participants (aged 18–65 years) with schizophrenia (ICD-10: F20.X) who required treatment initiation or a change in treatment, from 14 psychiatric university hospitals and state hospitals in Germany. Double randomisation allowed for restricted selection of a treatment within each antipsychotic drug group (FGA or SGA) for an individual patient: first, patients were assigned with a random number table to two of six possible drug pairs, each pair consisting of an FGA (haloperidol [3–6 mg] or flupentixol [6–12 mg]) given orally and an SGA (aripiprazole [10–20 mg], olanzapine [10–20 mg], or quetiapine [400–800 mg]) given orally, and the investigator then selected which pair was best suited to the patient; a second, double-blind random assignment allocated either the FGA or the SGA from the investigator-chosen pair to the patient. Treatment duration was 24 weeks. Primary outcomes were change from baseline to week 24 in quality of life (SF-36) and clinical global impression (CGI-I), analysed in all randomly assigned patients who received at least one dose of the study drug. Safety was assessed in a safety set, consisting of all randomly assigned patients who received at least one dose of the study drug, coinciding with the set of the efficacy analyses. The study is registered with ClinicalTrials.gov, number NCT01164059; German Clinical Trials Register, number DRKS00000304; WHO ICTRP, number U1111–1112–9727; and EudraCT, number 2009–010966–47. Findings Between April 1, 2010, and May 31, 2013, 149 patients were randomly assigned, 69 to FGA treatment and 80 to SGA treatment. 136 patients received at least one dose of study drug (63 in the FGA group, 73 in the SGA group). Mean area under the curve (AUC) values of SF-36 were significantly higher in the SGA group than in the FGA group (85·1 [SD 14·7] vs 79·7 [17·3], p=0·0112). Mean AUC values for CGI-I scores decreased in both groups, but were not significantly different between the two groups (3·39 [SD 0·89] in the FGA group vs 3·26 [0·92] in the SGA group, p=0·3423). 30 (48%) of 63 patients given FGAs had at least one adverse event compared with 42 (57%) of 73 patients given an SGA (p=0·3019); the most common were nervous system disorders (18 [60%] of 30 in the FGA group vs 19 [45%] of 42 in the SGA group) and psychiatric disorders (ten [33%] vs 16 [38%]). One patient died after cessation of study drug (olanzapine), most likely as a result of an illicit drug overdose. The increase in body-mass index (BMI) was significantly higher in the SGA group than in the FGA group (p=0·0021 at week 6 and p=0·0041 at week 24). Interpretation Improvement of patient-reported quality of life was significantly higher in patients with schizophrenia given SGAs than in those given FGAs, when treatment selection was individualised. This advantage, however, has to be weighed against the potential metabolic adverse effects of some SGAs. Funding German Federal Ministry of Education and Research.