Trial reportThe international journal of neuropsychopharmacology2017
Efficacy and Safety of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults with Schizophrenia: a Randomized, Double-Blind, Placebo-Controlled Study.
Trial report in The international journal of neuropsychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Antipsychotic Drugs and Dysregulated Glucose Homeostasis: A Systematic Review and Meta-Analysis.JAMA psychiatry · 2025Pooled it
- New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021Pooled it
- Reversibility of Antipsychotic-Induced Weight Gain: A Systematic Review and Meta-Analysis.Frontiers in endocrinology · 2021Pooled it
- Maintenance treatment with antipsychotic drugs for schizophrenia.The Cochrane database of systematic reviews · 2020Pooled it
- Medication-Induced Akathisia with Newly Approved Antipsychotics in Patients with a Severe Mental Illness: A Systematic Review and Meta-Analysis.CNS drugs · 2019Pooled it
- Effect of Brexpiprazole on Prolactin: An Analysis of Short- and Long-Term Studies in Schizophrenia.Journal of clinical psychopharmacologyPooled it
- A Long-Term, Open-Label Study to Evaluate the Safety and Tolerability of Brexpiprazole as Maintenance Treatment in Adults with Schizophrenia.The international journal of neuropsychopharmacology · 2018Trial
- Absolute Receptor Occupancy, Not Rate of Decline, Predicts Relapse.Schizophrenia bulletin · 2026Review
- Clinical Benefit and Risk Profile of TV-46000 for Patients with Schizophrenia as Assessed by Number Needed to Treat and Number Needed to Harm.Neuropsychiatric disease and treatment · 2026Article
- New pharmacological approaches in the treatment of schizophrenia.Pharmacological reports : PR · 2025Review
- Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia: A Long-Term, Open-Label Study.JAACAP open · 2025Article
- Third-Generation Antipsychotics: The Quest for the Key to Neurotrophism.Life (Basel, Switzerland) · 2025Review
- Brexpiprazole in the Management of Schizophrenia: A Consensus Report of Best Practices From Acute to Maintenance Treatment.Neuropsychiatric disease and treatment · 2025Article
- Unlocking the potential of lumateperone and novel anti-psychotics for schizophrenia.BioImpacts : BI · 2025Review
- Third-Generation Antipsychotics and Lurasidone in the Treatment of Substance-Induced Psychoses: A Narrative Review.Healthcare (Basel, Switzerland) · 2024Review
- Time-dependent effect of antipsychotic discontinuation and dose reduction on social functioning and subjective quality of life-a multilevel meta-analysis.EClinicalMedicine · 2023Article
- Efficacy of Serotonin and Dopamine Activity Modulators in the Treatment of Negative Symptoms in Schizophrenia: A Rapid Review.Biomedicines · 2023Review
- Brexpiprazole-Pharmacologic Properties and Use in Schizophrenia and Mood Disorders.Brain sciences · 2023Review
- New and emerging treatments for schizophrenia: a narrative review of their pharmacology, efficacy and side effect profile relative to established antipsychotics.Neuroscience and biobehavioral reviews · 2022Review
- Risk of Drug-induced Movement Disorders with Newer Antipsychotic Agents.Tremor and other hyperkinetic movements (New York, N.Y.) · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Brexpiprazole has previously demonstrated efficacy in acute schizophrenia trials. The objective of this trial was to assess the efficacy, safety, and tolerability of maintenance treatment with brexpiprazole in adults with schizophrenia. Methods: Patients with an acute exacerbation of psychotic symptoms were converted to brexpiprazole (1-4mg/d) over 1 to 4 weeks and entered a single-blind stabilization phase. Those patients who met stability criteria for 12 weeks were randomized 1:1 to double-blind maintenance treatment with either brexpiprazole (at their stabilization dose) or placebo for up to 52 weeks. The primary efficacy endpoint was the time from randomization to impending relapse. Safety and tolerability were also assessed. Results: A total of 524 patients were enrolled, 202 of whom were stabilized on brexpiprazole and randomized to brexpiprazole (n=97) or placebo (n=105). Efficacy was demonstrated at a prespecified interim analysis (conducted after 45 events), and so the trial was terminated early. The final analysis showed that time to impending relapse was statistically significantly delayed with brexpiprazole treatment compared with placebo (P<.0001, log-rank test). The hazard ratio for the final analysis was 0.292 (95% confidence interval: 0.156, 0.548); mean dose at last visit, 3.6mg. The proportion of patients meeting the criteria for impending relapse was 13.5% with brexpiprazole and 38.5% with placebo (P<.0001). During the maintenance phase, the incidence of adverse events was comparable to placebo. Conclusions: or patients with schizophrenia already stabilized on brexpiprazole, maintenance treatment with brexpiprazole was efficacious, with a favorable safety profile.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.