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To examine the predictive validity of early improvement in a naturalistic sample of inpatients and to identify the criterion that best defines early improvement.
Methods
Two hundred and forty-seven inpatients who fulfilled ICD-10 criteria for schizophrenia were assessed with the Positive And Negative Syndrome Scale (PANSS) at admission and at biweekly intervals until discharge from hospital. Remission was defined according to the recently proposed consensus criteria, response as a reduction of at least 40% in the PANNS total score from admission to discharge.
Results
Receiver operating characteristic (ROC) analyses showed that early improvement (reduction of the PANSS total score within the first 2 weeks of treatment) predicts remission (AUC = 0.659) and response (AUC = 0.737) at discharge. A 20% reduction in the PANSS total score within the first 2 weeks was the most accurate cut-off for the prediction of remission (total accuracy: 65%; sensitivity: 53%; specificity: 76%), and a 30% reduction the most accurate cut-off for the prediction of response (total accuracy: 76%; sensitivity: 47%; specificity: 90%).
Conclusion
The findings of clinical drug trials that early improvement is a predictor of subsequent treatment response were replicated in a naturalistic sample. Further studies should examine whether patients without early improvement benefit from an early change of antipsychotic medication.
To explore tolerability, safety and treatment response of flexible doses of oral paliperidone ER in patients with schizophrenia suffering from an acute episode.
Methods:
Interim analysis of a 6-week prospective, open-label, international study. Endpoints were the rate of responders defined as a ≥30% improvement in the Positive and Negative Syndrome Scale (PANSS) from baseline to endpoint, the Clinical Global Impression-Severity Scale (CGI-S), weight change and adverse events (AEs).
Results:
100 patients were analyzed (51% male, mean age 39.0±11.6 years). 82% of patients completed the study. Most frequent reasons for early discontinuation were subject choice (10%) and lack of efficacy (7%). the mean dose of paliperidone ER was 5.9 mg/day at baseline and 7.9 mg/day at endpoint. an improvement of ≥30% in total PANSS was observed in 68% of patients (95% confidence interval [CI]58%;77%], with a decrease in mean total PANSS scores from 98.2±16.2 at baseline to 71.1±20.3 at endpoint (mean change -27.1±19.9; 95%CI -31.1;-23.2, p< 0.0001) and onset of efficacy as of day 2. the percentage of patients rated as at least markedly ill in CGI-S decreased from 69% to 20.3%. AEs reported in ≥5% were insomnia (14%), tachycardia (10%), akathisia (6%), extrapyramidal disorder (6%), headache (5%) and schizophrenia (5%). Median weight gain was 0.7 kg (95% CI 0.19;1.96) from baseline to endpoint.
Conclusion:
This analysis supports data from recent controlled studies that flexibly dosed paliperidone ER is safe, well tolerated and associated with a clinically meaningful treatment response in patients with an acute schizophrenic episode.
Aim was to examine depressive symptoms in acutely ill schizophrenia patients on a single symptom basis and to evaluate their relationship with positive, negative and general psychopathological symptoms.
Methods:
Two hundred and seventy-eight patients suffering from a schizophrenia spectrum disorder were analysed within a naturalistic study by the German Research Network on Schizophrenia. Using the Calgary Depression Scale for Schizophrenia (CDSS) depressive symptoms were examined and the Positive and Negative Syndrome Scale (PANSS) was applied to assess positive, negative and general symptoms. Correlation and factor analyses were calculated to detect the underlying structure and relationship of the patient’s symptoms.
Results:
The most prevalent depressive symptoms identified were depressed mood (80%), observed depression (62%) and hopelessness (54%). Thirty-nine percent of the patients suffered from depressive symptoms when applying the recommended cut-off of a CDSS total score of > 6 points at admission. Negligible correlations were found between depressive and positive symptoms as well as most PANSS negative and global symptoms despite items on depression, guilt and social withdrawal. The factor analysis revealed that the factor loading with the PANSS negative items accounted for most of the data variance followed by a factor with positive symptoms and three depression-associated factors.
Limitations:
The naturalistic study design does not allow a sufficient control of study results for the effect of different pharmacological treatments possibly influencing the appearance of depressive symptoms.
Conclusion:
Results suggest that depressive symptoms measured with the CDSS are a discrete symptom domain with only partial overlap with positive or negative symptoms.
Although shared decision-making (SDM) has the potential to improve health outcomes, psychiatrists often exclude patients with more severe mental illnesses or more acute conditions from participation in treatment decisions. This study examines whether SDM is facilitated by an approach which is specifically adapted to the needs of acutely ill patients (SDM-PLUS).
Methods
The study is a multi-centre, cluster-randomised, non-blinded, controlled trial of SDM-PLUS in 12 acute psychiatric wards of five psychiatric hospitals addressing inpatients with schizophrenia or schizoaffective disorder. All patients fulfilling the inclusion criteria were consecutively recruited for the trial at the time of their admission to the ward. Treatment teams of intervention wards were trained in the SDM-PLUS approach through participation in two half-day workshops. Patients on intervention wards received group training in SDM. Staff (and patients) of the control wards acted under ‘treatment as usual’ conditions. The primary outcome parameter was the patients' perceived involvement in decision-making at 3 weeks after study enrolment, analysed using a random-effects linear regression model.
Results
In total, 161 participants each were recruited in the intervention and control group. SDM-PLUS led to higher perceived involvement in decision-making (primary outcome, analysed patients n = 257, mean group difference 16.5, 95% CI 9.0–24.0, p = 0.002, adjusted for baseline differences: β 17.3, 95% CI 10.8–23.6, p = 0.0004). In addition, intervention group patients exhibited better therapeutic alliance, treatment satisfaction and self-rated medication compliance during inpatient stay. There were, however, no significant improvements in adherence and rehospitalisation rates in the 6- and 12-month follow-up.
Conclusions
Despite limitations in patient recruitment, the SDM-PLUS trial has shown that the adoption of behavioural approaches (e.g. motivational interviewing) for SDM may yield a successful application to mental health. The authors recommend strategies to ensure effects are not lost at the interface between in- and outpatient treatment.
Trial registration: The trial was registered at Deutsches Register Klinischer Studien (DRKS00010880).
To analyse insight of illness during the course of inpatient treatment, and to identify influencing factors and predictors of insight.
Methods
Insight into illness was examined in 399 patients using the item G12 of the Positive and Negative Syndrome Scale (“lack of insight and judgement”). Ratings of the PANSS, HAMD, UKU, GAF, SOFAS, SWN-K and Kemp's compliance scale were performed and examined regarding their potential association with insight. The item G12 was kept as an ordinal variable to compare insight between subgroups of patients.
Results
Almost 70% of patients had deficits in their insight into illness at admission. A significant improvement of impairments of insight during the treatment (p<0.0001) was observed. At admission more severe positive and negative symptoms, worse functioning and worse adherence were significantly associated with poorer insight. Less depressive symptoms (p = 0.0004), less suicidality (p = 0.0218), suffering from multiple illness-episodes (p<0.0001) and worse adherence (p = 0.0012) at admission were identified to be significant predictors of poor insight at discharge.
Conclusion
The revealed predictors might function as treatment targets in order to improve insight and with it outcome of schizophrenia.
Studies in urban areas identified environmental risk factors for mental illness, but little research on this topic has been performed in rural areas.
Methods.
Hospital admission rates were computed for 174 rural municipalities in the catchment area of the state psychiatric hospital in Günzburg in years 2006 to 2009 and combined with structural and socio-economic data. Relationships of overall and diagnosis-specific admission rates with municipality characteristics were analysed by means of negative binomial regression models.
Results.
Admission rates of patients with a diagnosis of schizophrenia and affective disorder combined decrease with increasing population growth, population density, average income and green areas, while admission rates are positively correlated with commuter balance, income inequality, unemployment rates and traffic areas. Admission rates for schizophrenia are negatively related to population growth, average income and agricultural areas, but positively related to mobility index, income inequality and unemployment rate. Admission rates for affective disorders are negatively related to population growth, population density, average income and green areas, while higher admission rates are correlated with commuter balance, high income inequality, unemployment rate and traffic-related areas.
Conclusions.
Effects of wealth, economic inequality, population density and structural area characteristics influence psychiatric admission rates also in rural areas.
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