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A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia.

ABSTRACT: Background:Brexpiprazole is a serotonin-dopamine activity modulator with efficacy in acute schizophrenia and relapse prevention. The aim of this Phase 3, multicenter study was to assess the long-term safety, tolerability, and efficacy of treatment with brexpiprazole flexible-dose 1-4 mg/d. Methods:Patients rolled over into this 52-week open-label study (amended to 26 weeks towards the end) from 3 randomized, double-blind, placebo-controlled Phase 3 studies. De novo patients, not part of the previous studies, were also enrolled. The primary outcome variable was the frequency and severity of treatment-emergent adverse events. Efficacy was assessed as a secondary objective using the Positive and Negative Syndrome Scale and the Personal and Social Performance scale. Results:A total of 1072 patients was enrolled (952 for 52 weeks and 120 for 26 weeks), 47.4% of whom completed the study. Among patients who took at least one dose of brexpiprazole, 14.6% discontinued due to treatment-emergent adverse events, most commonly schizophrenia (8.8%) and psychotic disorder (1.5%). Treatment-emergent adverse events with an incidence of ?5% were schizophrenia (11.6%), insomnia (8.6%), weight increased (7.8%), headache (6.4%), and agitation (5.4%). Most treatment-emergent adverse events were mild or moderate in severity. The mean increase in body weight from baseline to week 26 was 1.3 kg and to week 52 was 2.1 kg. There were no clinically relevant findings related to prolactin, lipids, and glucose, or QT prolongation. On average, patients' symptoms and functioning showed continual improvement. Conclusions:Treatment with brexpiprazole 1-4 mg/d was generally well tolerated for up to 52 weeks in patients with schizophrenia. ClinicalTrials.gov identifier:NCT01397786 (https://clinicaltrials.gov/show/NCT01397786).

SUBMITTER: Forbes A

PROVIDER: S-EPMC5932477 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Project description:BackgroundProbiotics are among the most commonly used dietary supplements and evidence of their efficacy is increasing. Despite the long historical use of probiotics, some experts suggest that additional research is necessary to understand their potential risks.ObjectivesMain aims of this study were to assess short-term tolerability and safety of a new, high colony-forming unit count, multi-strain probiotic supplement. Exploratory objectives included evaluating effects on gut microbial composition.MethodsTen healthy adults were enrolled in a single-arm, open-label study. Over a 10-day period, participants consumed a once daily probiotic capsule (2.1 x 1011 CFU) containing Lactobacillus acidophilus NCFM, Lactobacillus paracasei Lpc-37, Lactobacillus plantarum Lp-115, Lactobacillus rhamnosus GG, Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis Bl-04, and Bifidobacterium lactis HN019. The primary measure of tolerability pertained to whether or not participants completed the study. Secondary safety measures included clinical biomarkers from a routine metabolic panel and a complete blood count. Exploratory measures included stool microbiota counts.ResultsAll participants completed the study and there were no serious adverse events. All documented adverse events were prompted by the investigators and the most commonly reported symptoms were gastrointestinal. There was a single instance of a biomarker abnormality in one individual. Overall, decreases in total bilirubin and aspartate aminotransferase, and increases in stool levels of Lactobacillus species, Faecalibacterium prausnitzii, and Akkermansia muciniphila (P < .05) were observed over the course of the study.ConclusionsThe findings of this study suggest the multi-strain probiotic supplement was well-tolerated and most likely safe. Changes in liver function measures suggest the probiotics could potentially impact liver health. Stool microbiota changes suggest the probiotic could potentially impact gut health by affecting levels of intestinal microbiota that have been described as bioindicators of health and potential keystone species. However, additional research is necessary to follow up on the exploratory findings of this preliminary work.

Dataset Information

A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia.

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