Drug updated on 11/10/2023

Dosage FormCapsules (oral; 1.5 mg, 3 mg, 4.5 mg, 6 mg)
Drug ClassAtypical antipsychotics
Ongoing and Completed StudiesClinicalTrials.gov


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

Product Monograph / Prescribing Information

Document TitleYearSource
Vraylar (cariprazine) Prescribing Information.2019Allergan USA, Inc., Madison, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Clinical and pharmacoeconomic combined report.2023CADTH
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-analysis2023The lancet. Psychiatry
Cariprazine for treating psychosis: an updated meta-analysis2023International 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-analysis2023Psychological medicine
Antipsychotic dose, dopamine D2 receptor occupancy and extrapyramidal side-effects: a systematic review and dose-response meta-analysis2023Molecular 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
Efficacy and acceptability of second-generation antipsychotics with antidepressants in unipolar depression augmentation: a systematic review and network meta-analysis2022Psychological 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-analysis2022Lancet
Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials2022Molecular psychiatry
A cumulative Bayesian network meta-analysis on the comparative efficacy of pharmacotherapies for mania over the last 40 years2022Psychopharmacology
Variability and efficacy in treatment effects on manic symptoms with lithium, anticonvulsants, and antipsychotics in acute bipolar mania: A systematic review and meta-analysis2022EClinicalMedicine
Australian public assessment report for cariprazine hydrochloride. 2021Australian Government: Department of Health
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. Lithium2021Journal of psychopharmacology
Cariprazine in the treatment of bipolar disorder: a systematic review and meta‚Äźanalysis.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 Trials2020Journal 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
Pharmacological interventions for treatment-resistant depression in adults2019The Cochrane database of systematic reviews
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
Use of cariprazine in psychiatric disorders: a systematic review.2018Annals of Clinical Psychiatry: Official Journal of the American Academy of Clinical Psychiatrists
Treatment for bipolar disorder in adults: a systematic review.2018AHRQ
Canadian network for mood and anxiety treatments (canmat) and international society for bipolar disorders (isbd) 2018 guidelines for the management of patients with bipolar disorder.2018Bipolar Disorders An International Journal of Psychiatry and Neurosciences
Antipsychotic drugs for patients with schizophrenia and predominant or prominent negative symptoms: a systematic review and meta-analysis2018European archives of psychiatry and clinical neuroscience
Tolerability and safety profile of cariprazine in treating psychotic disorders, bipolar disorder and major depressive disorder: a systematic review with meta-analysis of randomized controlled trials2016CNS Drugs

Clinical Practice Guidelines