Trial reportPsychopharmacology2017
Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study.
Trial report in Psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.
What it found
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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
27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.
- Real-Life Clinical Experience With Cariprazine: A Systematic Review of Case Studies.Frontiers in psychiatry · 2022Pooled it
- New Antipsychotic Medications in the Last Decade.Current psychiatry reports · 2021Pooled 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
- Long-term safety and tolerability of cariprazine as adjunctive therapy in major depressive disorder.International clinical psychopharmacology · 2019Trial
- 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
- Budget impact of xanomeline and trospium chloride for the treatment of adults with schizophrenia in the United States.Journal of managed care & specialty pharmacy · 2026Article
- Effects of cariprazine on cholesterol, glucose, and weight in patients with schizophrenia: a systematic review and meta-analysis.Therapeutic advances in psychopharmacology · 2026Article
- Xanomeline-Trospium: A Novel Therapeutic for the Treatment of Schizophrenia.The Annals of pharmacotherapy · 2025Review
- Physical illness in schizophrenia and the role of tolerability in antipsychotic selection: an expert consensus with a focus on cariprazine.Annals of general psychiatry · 2025Review
- Clinical challenges in the dosing and titration of cariprazine.Frontiers in psychiatry · 2024Article
- Cariprazine in an Adolescent with Tourette Syndrome with Comorbid Attention Deficit Hyperactive Disorder and Depression: A Case Report.Healthcare (Basel, Switzerland) · 2023Article
- Cariprazine for Treating Schizophrenia, Mania, Bipolar Depression, and Unipolar Depression: A Review of Its Efficacy.Cureus · 2023Review
- Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia.Neuropsychiatric disease and treatment · 2022Article
- Symptomatic Profile of Cariprazine in the Context of ICD-11 Domains for Schizophrenia: Review of Clinically Oriented Studies: Симптоматический профиль карипразина в контексте доменов шизофрении в МКБ -11: обзор клинически ориентированных исследований.Consortium psychiatricum · 2022Review
- Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety.Advances in therapy · 2021Review
- Dosing Cariprazine Within and Beyond Clinical Trials: Recommendations for the Treatment of Schizophrenia.Frontiers in psychiatry · 2021Article
- Population Pharmacokinetics of Cariprazine and its Major Metabolites.European journal of drug metabolism and pharmacokinetics · 2021Article
- Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies.Neuropsychiatric disease and treatment · 2021Article
- Cariprazine: Patients with Treatment-Resistant Schizophrenia.Neuropsychiatric disease and treatment · 2021Article
- Negative Symptoms of Schizophrenia: New Prospects of Cariprazine Treatment.Consortium psychiatricum · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
rationaleCariprazine, a dopamine D
objectiveThis single-arm, open-label extension study evaluated the long-term safety and tolerability of cariprazine in patients with schizophrenia.
methodsPatients enrolled in this study completed a 6-week, randomized, placebo- and active-controlled study and had responded (Clinical Global Impressions-Severity [CGI-S] ≤3; ≥20 % reduction in Positive and Negative Syndrome Scale [PANSS] total score) to treatment at the end of the lead-in study. Patients (N = 93) received flexibly dosed, open-label cariprazine (1.5-4.5 mg/day) for up to 48 weeks.
resultsApproximately 50 % (46/93) of patients completed the 48 weeks of open-label treatment. The most common adverse events (AEs) were akathisia (14 %), insomnia (14 %), and weight increased (12 %). Serious AEs (SAEs) occurred in 13 % of patients; 11 % discontinued due to AEs. Mean changes in metabolic parameters were generally small and not clinically relevant. Mean body weight increased by 1.9 kg from the start of the lead-in study to the end of the extension study. There were no discontinuations associated with change in metabolic parameters or body weight. Long-term cariprazine treatment was not associated with prolactin elevation or clinically significant changes in cardiovascular parameters.
conclusionsIn this 48-week, single-arm trial, open-label cariprazine (1.5-4.5 mg/day) treatment was generally safe and well tolerated with no new safety concerns associated with long-term treatment.
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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.