Drug updated on 5/17/2024

Dosage FormCapsules (oral; 1.5 mg, 3 mg, 4.5 mg, 6 mg)
Drug ClassAntipsychotics
Ongoing and
Completed Studies


  • Indicated for treatment of schizophrenia in adults.
  • Indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
  • Indicated for treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
  • Indicated for adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

Latest News

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  • Cariprazine (Vraylar) is a dopamine partial agonist used for its antidepressant effects, particularly in treatment-resistant depression. It has been compared with aripiprazole and brexpiprazole, showcasing effectiveness in the order of aripiprazole, brexpiprazole, then cariprazine.
  • The information was derived from 26 systematic reviews/meta-analyses documents that focused on comparisons with other medications in terms of safety and effectiveness.
  • Cariprazine's efficacy extends beyond treatment-resistant depression to managing schizophrenia, bipolar I disorder, including manic, mixed, and depressive episodes, as well as an adjunctive therapy for major depressive disorder (MDD).
  • Compared to various atypical antipsychotics (AAPs) and mood stabilizers, cariprazine stands out due to its notable effectiveness in treating bipolar depression along with acute manic or mixed episodes while maintaining a good safety profile.
  • The medication's dosage plays a crucial role when comparing it against other dopamine partial agonists and atypical antipsychotics. Side effects such as akathisia and weight gain can be mitigated by careful management of administration while achieving the desired therapeutic outcomes.
  • Population types, like different ethnic groups or age brackets, have variability in their response towards this medication, which underscores the need for personalized treatment planning, especially among patients suffering from schizophrenia or bipolar disorders.
  • Systematic reviews/meta-analyses highlight a comparative advantage over placebo in reducing depressive symptoms and improving remission rates regardless of the primary psychiatric diagnosis, reinforcing its significance in treating both bipolar disorder and schizophrenia.
  • Clinical trials and real-world case reports support Vraylar’s safety and efficacy across various psychiatric symptoms and conditions, with early protocols especially for diagnostic differentiation between challenging cases, indicating its utility in wider scenarios.

Product Monograph / Prescribing Information

Document TitleYearSource
Vraylar (cariprazine) Prescribing Information.2024Allergan USA, Inc., Madison, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative efficacy of dopamine partial agonists by doses for treatment-resistant depression: a systematic review and dose-response model-based network meta-analysis.2024Journal of Clinical Psychopharmacology
Adjunctive cariprazine for major depressive disorder: a systematic review and meta-analysis.2024CNS Spectrums
Adjunctive cariprazine as a novel effective strategy for treating major depressive disorder: a systematic review and meta-analysis.2024Journal of Psychiatric Research
Comparison of antipsychotic dose equivalents for acute bipolar mania and schizophrenia.2023BMJ Mental Health
Efficacy and safety profiles of mood stabilizers and antipsychotics for bipolar depression: a systematic review.2023International Clinical Psychopharmacology
Systematic literature review and network meta-analysis of lurasidone, brexpiprazole, and cariprazine for schizophrenia.2023International Clinical Psychotherapy
Comparative efficacy and tolerability of pharmacological interventions for acute bipolar depression in adults: a systematic review and network meta-analysis.2023The Lancet. Psychiatry
Cariprazine for treating psychosis: an updated meta-analysis.2023International Journal of Psychiatry in Clinical Practice
Efficacy and safety/tolerability of antipsychotics in the treatment of adult patients with major depressive disorder: a systematic review and meta-analysis.2023Psychological Medicine
Antipsychotic dose, dopamine D2 receptor occupancy, and extrapyramidal side-effects: a systematic review and dose-response meta-analysis.2023Molecular Psychiatry
Antipsychotic-induced weight gain: dose-response meta-analysis of randomized controlled trials.2022The Journal of Psychoses and Related Disorders
Augmentation strategies for treatment-resistant major depression: a systematic review and network meta-analysis.2022Journal of Affective Disorders
Real-life clinical experience with cariprazine: a systematic review of case studies.2022Frontiers in Psychiatry
Variability and efficacy in treatment effects on manic symptoms with lithium, anticonvulsants, and antipsychotics in acute bipolar mania: a systematic review and meta-analysis.2022EClinicalMedicine
Efficacy and acceptability of second-generation antipsychotics with antidepressants in unipolar depression augmentation: a systematic review and network meta-analysis.2022Psychological Medicine
Comparative efficacy and tolerability of 32 oral and long-acting injectable antipsychotics for the maintenance treatment of adults with schizophrenia: a systematic review and network meta-analysis.2022Lancet
Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials.2022Molecular Psychiatry
A cumulative Bayesian network meta-analysis on the comparative efficacy of pharmacotherapies for mania over the last 40 years.2022Psychopharmacology
New developments in the use of atypical antipsychotics in the treatment of bipolar disorder: a systematic review of recent randomized controlled trials.2021Current Psychiatry Reports
Efficacy and tolerability of atypical antipsychotics for acute bipolar depression: a network meta-analysis.2021BMC Psychiatry
Efficacy and tolerability of combination treatments for major depression: antidepressants plus second-generation antipsychotics vs. esketamine vs. lithium.2021Journal of Psychopharmacology
Cariprazine in the treatment of bipolar disorder: a systematic review and meta‐analysis.2020Bipolar Disorders
Comparative efficacy and tolerability of pharmacological treatments for the treatment of acute bipolar depression: a systematic review and network meta-analysis.2020Journal of Affective Disorders
Acceptability of acute and maintenance pharmacotherapy of bipolar disorder: a systematic review of randomized, double-blind, placebo-controlled clinical trials.2020Journal of Clinical Psychopharmacology
Dose-response meta-analysis of antipsychotic drugs for acute schizophrenia.2019The American Journal of Psychiatry
Medication-induced akathisia with newly approved antipsychotics in patients with a severe mental illness: a systematic review and meta-analysis.2019CNS Drugs
Cariprazine for bipolar depression: what is the number needed to treat, number needed to harm and likelihood to be helped or harmed?2019International Journal of Clinical Practice
Pharmacological interventions for treatment-resistant depression in adults.2019The Cochrane Database of Systematic Reviews

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