ArticleNeuropsychiatric disease and treatment2021
Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies.
Article in Neuropsychiatric disease and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 7 registered trials, which are not on this map. Cited by 26 papers, 2 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.
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia
A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Cariprazine (RGH-188) in the Prevention of Relapse in Patients With Schizophrenia
Who cites it
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 44 citations in OpenAlex.
- Cariprazine and clozapine: a systematic review of a promising antipsychotic combination for treatment-resistant schizophrenia.The international journal of neuropsychopharmacology · 2025Pooled it
- Real-Life Clinical Experience With Cariprazine: A Systematic Review of Case Studies.Frontiers in psychiatry · 2022Pooled it
- Cariprazine Orodispersible Tablet: A New Formulation for Cariprazine.Pharmacopsychiatry · 2024Trial
- Cariprazine-induced obsessive-compulsive symptoms in a patient with bipolar II disorder: A case report.Biomedical reports · 2026Article
- Cariprazine and Lithium Overdose: A Case Report.Cureus · 2026Article
- Improvement in Antipsychotic-Related Sexual Dysfunction After Switching to Cariprazine: A Prospective Real-World Study.Journal of clinical medicine · 2026Article
- Effects of cariprazine on cholesterol, glucose, and weight in patients with schizophrenia: a systematic review and meta-analysis.Therapeutic advances in psychopharmacology · 2026Article
- Transdiagnostic Efficacy of Cariprazine: A Systematic Review and Meta-Analysis of Efficacy Across Ten Symptom Domains.Pharmaceuticals (Basel, Switzerland) · 2025Review
- New pharmacological approaches in the treatment of schizophrenia.Pharmacological reports : PR · 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
- Efficacy of xanomeline and trospium chloride in schizophrenia: pooled results from three 5-week, randomized, double-blind, placebo-controlled, EMERGENT trials.Schizophrenia (Heidelberg, Germany) · 2024Article
- Coadministration of Cariprazine with a Moderate CYP3A4 Inhibitor in Patients with Schizophrenia: Implications for Dose Adjustment and Safety Monitoring.Clinical pharmacokinetics · 2024Article
- Clinical challenges in the dosing and titration of cariprazine.Frontiers in psychiatry · 2024Article
- A review on the pharmacology of cariprazine and its role in the treatment of negative symptoms of schizophrenia.Frontiers in psychiatry · 2024Review
- Exploring cariprazine as a treatment option for varied depression symptom clusters.Frontiers in psychiatry · 2024Review
- The improvement of motor symptoms in Huntington's disease during cariprazine treatment.Orphanet journal of rare diseases · 2023Article
- Cariprazine in an Adolescent with Tourette Syndrome with Comorbid Attention Deficit Hyperactive Disorder and Depression: A Case Report.Healthcare (Basel, Switzerland) · 2023Article
- Therapeutic Appropriateness of Cariprazine in the Management of Schizophrenia: Experts' Opinion using a Delphi Approach.Current neuropharmacology · 2023Article
- Successful high dose antipsychotic treatment with cariprazine in patients on the schizophrenia spectrum: Real-world evidence from a Spanish hospital setting.Frontiers in psychiatry · 2023Article
- 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
Corrections and comments
- Erratum issued
Authors and funding
7 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLong-term treatment with antipsychotic agents is indicated for patients with schizophrenia, but treatment is associated with adverse events (AEs) that contribute to medication discontinuation and nonadherence. Understanding drug safety profiles is critical to avoid unwanted side effects. Cariprazine is a potent dopamine D
methodsPost hoc analyses were conducted to characterize the safety profile of cariprazine within the recommended 1.5-6 mg/d dose range for schizophrenia; data from 8 short- or long-term clinical trials were analyzed.
resultsIn the pooled cariprazine-treated safety population (n=2048), the rate of study completion was 52.8%, with withdrawal of consent, insufficient response, and AEs the most common reasons for premature discontinuation. The most commonly reported AEs (>10%) in the overall cariprazine-treatment group were akathisia (14.6%), insomnia (14.0%), and headache (12.1%); most AEs were considered mild (71.0%) or moderate (26.5%). Most akathisia was mild/moderate (97.5%) and >93% of patients remained on treatment; akathisia events were managed by rescue medications (56.3%) or dose reduction (18.3%). The metabolic profile of cariprazine was neutral in patients with short- and long-term exposure; mean weight gain was 1 kg for overall cariprazine, with an AE of weight increased reported for 5.1%. Other AEs of special interest that occurred at >3% for overall cariprazine were extrapyramidal disorder (7.0%), sedation (3.7%), and somnolence (3.1%); prolactin elevation, cognition impairment, sexual dysfunction, suicidality, and QT prolongation occurred at ≤1%.
conclusionAkathisia, the most common cariprazine-related AE, was mild/moderate and resulted in few study discontinuations; symptoms were well managed and most patients remained on treatment. Results of this analysis indicated that cariprazine in the recommended dose range was safe and generally well tolerated in patients with schizophrenia.
trial registrationStudies registered with ClinicalTrials.gov (NCT00404573, NCT01104779, NCT00694707, NCT01104766, NCT01104792, NCT00839852, and NCT01412060) and EudraCT (2012-005485-36).
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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.