Trial reportBipolar disorders2020
Efficacy and safety of cariprazine in bipolar I depression: A double-blind, placebo-controlled phase 3 study.
Trial report in Bipolar disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02670538 (A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression), which is not on this map. Cited by 32 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.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating The Efficacy, Safety And Tolerability Of Cariprazine In Patients With Bipolar I Depression
Who cites it
32 citing papers in PubMed, 6 syntheses or guidelines pooled it, 244 citations in OpenAlex.
- Depressive disorders: systematic review of approved psychiatric medications (2009-April 2025) and pipeline phase 3 medications.BMC psychiatry · 2025Pooled it
- Pooled it
- Efficacy and tolerability of FDA-approved atypical antipsychotics for the treatment of bipolar depression: a systematic review and network meta-analysis.European psychiatry : the journal of the Association of European Psychiatrists · 2024Pooled it
- Real-Life Clinical Experience With Cariprazine: A Systematic Review of Case Studies.Frontiers in psychiatry · 2022Pooled it
- Efficacy and tolerability of atypical antipsychotics for acute bipolar depression: a network meta-analysis.BMC psychiatry · 2021Pooled it
- New Developments in the Use of Atypical Antipsychotics in the Treatment of Bipolar Disorder: a Systematic Review of Recent Randomized Controlled Trials.Current psychiatry reports · 2021Pooled it
- Lumateperone monotherapy for major depressive episodes associated with bipolar disorder: efficacy and safety in a randomized placebo-controlled trial.International clinical psychopharmacology · 2026Trial
- Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials.CNS spectrums · 2025Trial
- Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials.Advances in therapy · 2025Trial
- Efficacy and safety of cariprazine in bipolar I depression: A double-blind, placebo-controlled phase 3 study.Bipolar disorders · 2020Trial
- Real-World Assessment of Healthcare Resource Utilization-Defined Manic and Depressive Events Among Patients with Bipolar I Disorder Treated with Cariprazine Versus Aripiprazole.Advances in therapy · 2026Article
- Transdiagnostic Efficacy of Cariprazine: A Systematic Review and Meta-Analysis of Efficacy Across Ten Symptom Domains.Pharmaceuticals (Basel, Switzerland) · 2025Review
- ESG-1-60 and ESG-1-61: Novel dopamine DBritish journal of pharmacology · 2025Article
- Global Trends in the Use of Pharmacotherapy for the Treatment of Bipolar Disorder.Current psychiatry reports · 2025Review
- Cariprazine in Bipolar Disorder and Substance Use: A Dual Approach to Treatment?Pharmaceuticals (Basel, Switzerland) · 2024Review
- Cariprazine in Psychiatry: A Comprehensive Review of Efficacy, Safety, and Therapeutic Potential.Medical science monitor : international medical journal of experimental and clinical research · 2024Review
- Advances in Mood Disorder Pharmacotherapy: Evaluating New Antipsychotics and Mood Stabilizers for Bipolar Disorder and Schizophrenia.Medical science monitor : international medical journal of experimental and clinical research · 2024Review
- Clinical challenges in the dosing and titration of cariprazine.Frontiers in psychiatry · 2024Article
- The CANMAT and ISBD Guidelines for the Treatment of Bipolar Disorder: Summary and a 2023 Update of Evidence.Focus (American Psychiatric Publishing) · 2023Review
- Cariprazine in Pediatric Patients with Autism Spectrum Disorder: Results of a Pharmacokinetic, Safety and Tolerability Study.Journal of child and adolescent psychopharmacology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538).
methodsIn this phase 3 double-blind placebo-controlled study, adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5th Edition criteria and a current depressive episode were randomized to placebo (n = 167), cariprazine 1.5 mg/day (n = 168) or cariprazine 3.0 mg/day (n = 158). Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed-model for repeated measures was used to estimate the least-squares mean differences (LSMD); P-values were adjusted for multiplicity. Adverse events (AEs), laboratory results, vital signs, and suicide risk were monitored.
resultsCariprazine 1.5 mg/day significantly reduced depressive symptoms on the primary (MADRS LSMD = -2.5; adjusted P = .0417) and secondary (CGI-S LSMD = -0.3; adjusted P = .0417) efficacy parameters vs placebo; differences were not statistically significant for cariprazine 3.0 mg/day. Common treatment-emergent AEs (≥5% in either cariprazine group and at least twice the incidence of placebo) were akathisia, restlessness, nausea, and fatigue. Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups.
conclusionsCariprazine 1.5 mg/day significantly reduced depressive symptoms in adults with bipolar I depression compared to placebo, but differences were not significant for cariprazine 3.0 mg/day. The safety and tolerability profiles were similar to previous studies of cariprazine.
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.