Preliminary data from a 4-year mirror-image and multicentre study of patients initiating paliperidone palmitate 6-monthly long-acting injectable antipsychotic: the Paliperidone 2 per Year study.

Background: Paliperidone palmitate 6-monthly (PP6M) is the first long-acting antipsychotic injectable (LAI) to allow for only two medication administrations per year, though there is presently limited insight into its effectiveness and potential added value in real clinical practice conditions. Objectives: To present our ongoing study and draw its preliminary data on patient characteristics initiating PP6M and adherence during the first year of treatment. Methods: The paliperidone 2 per year (P2Y) study is a 4-year, multicentre, prospective mirror-image pragmatic study taking place at over 20 different sites in Europe. The mirror period covers 2 years either side of the PP6M LAI initiation. Retrospective data for the previous 2 years are collected for each patient from the electronic health records. Prospective data are recorded at baseline, 6, 12, 18 and 24 months of drug administration and also cover information on concomitant psychiatric medication, relapses, hospital admissions, side effects, discontinuation and its reasons. Meanwhile, here we present preliminary data from the P2Y study at basal and 6-month period (first and second PP6M administration). Results: At the point of PP6M initiation, the most frequent diagnosis was schizophrenia (69%), the clinical global impression scale mean score was 3.5 (moderately markedly ill) and the rate of previous hospital admissions per patient and year was 0.21. PP6M was initiated after a median of 3-4 years on previous treatment: 146 (73%) from paliperidone palmitate 3-monthly, 37 (19%) from paliperidone palmitate 1-monthly and 17 (9%) from other antipsychotics. The mean dose of the first PP6M was 1098.9 mg. The retention rate at 6 months and 1 year of treatment on PP6M in our cohort was 94%. Conclusion: Patient and clinician preference for LAIs with longer dosing intervals was the main reason for PP6M initiation/switching resulting in high treatment persistence. Future data are needed to evaluate the full impact of PP6M in clinical practice.

Lifestyle intervention based on exercise and behavioural counselling and its effect on physical and psychological health in outpatients with schizophrenia spectrum disorders. An exploratory, pragmatic randomized clinical trial.

Patients with Schizophrenia Spectrum Disorders (SSD) often lead unhealthy lifestyles. This pragmatic trial evaluated the effectiveness of a lifestyle intervention, consisting of a 12-week aerobic exercise program and behavioural counselling, in SSD outpatients with metabolic syndrome (MetS). It also aimed to assess persistence of potential effects in a 24-month long-term follow-up. Effectiveness was measured in terms of a wide range of outcomes involving physical and psychological health, quality of life, physical activity and changes in motivation to exercise within the context of the self-determination theory. Our primary outcome was waist circumference change. Thirty-three out of 48 participants completed the study. No differences between groups were found in terms of BMI change or other metabolic parameters. However, the active group (AG) showed improvement regarding waist circumference, negative symptomatology and identified motivation to exercise during the study and follow-up. The AG exhibited changes toward a more active pattern of activity after intervention. Moreover, belonging to the AG was a significant predictor for achieving any degree of clinical improvement after 24-month follow-up. Combined interventions of exercise and behavioural counselling in SSD patients with MetS should be considered as an essential part of the integral treatment in the context of mental health services.

In- and outpatient lifestyle interventions on diet and exercise and their effect on physical and psychological health: a systematic review and meta-analysis of randomised controlled trials in patients with schizophrenia spectrum disorders and first episode of psychosis.

Patients with non-affective psychosis often lead unhealthy lifestyles. We performed a systematic review and meta-analysis on non-pharmacological RCTs for improvement of diet and physical activity in non-affective psychosis patients, including first-episode psychosis. A variety of outcomes was analysed, including metabolic, psychopathology, cognitive, functional and quality of life outcomes. Fifty-nine studies were included. An improvement in anthropometric measurements (BMI, weight, waist circumference) was observed post-intervention, persisting after follow-up. Post-intervention benefit was found also for psychotic symptoms severity (also persisting after follow-up), many cognitive domains and physical and global functioning and quality of life. Conversely, no effect was observed in relation to most blood metabolites, blood pressure and non-psychotic psychopathology and spontaneous physical activity. Improvement was generally larger for interventions including exercise, especially moderate/vigorous aerobic exercise, but follow-up maintenance was greater for psychotherapy interventions. Sensitivity analyses limited to chronic stages of psychosis and low risk of bias studies produced comparable results. Further studies are needed to design optimized interventions in this vulnerable population.

Long-acting injectable aripiprazole in pregnant women with schizophrenia: a case-series report.

Antipsychotic long-acting formulations (LAI-AP) have emerged as a new therapeutic choice to treat patients presenting a severe mental disorder. Despite that, to date, there is a lack of safety data and studies regarding the use of LAI-AP formulations in pregnant women. Here we present the first six-case series of pregnant women with schizophrenia treated with aripiprazole-LAI reported in the literature. All patients remained psychopathologically stable through pregnancy and the postpartum period, and all of them were in treatment with aripiprazole-LAI. To date, all infants remain healthy with normal developmental milestones, without the presence of congenital malformations or adverse effects. Lack of information on safety data regarding the use of new antipsychotic formulations remains important in treating women with mental illness who desire to become pregnant. Further studies in this clinical population with a larger number of patients included remains necessary.