Cariprazine

(Vraylar®)

Vraylar®

Drug updated on 9/4/2024

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

Indication

  • 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.

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Summary
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  • Vraylar (cariprazine) is indicated for the treatment of schizophrenia in adults, the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults, and as adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
  • This summary is based on the review of 28 systematic review(s)/meta-analysis(es). [1-28]
  • Treatment-Resistant Depression (TRD): Cariprazine demonstrated moderate antidepressant effects with a standardized mean difference (SMD) in MADRS scores of -1.79 (95% CI: -2.89, -0.69) and improved MADRS response rates (RR = 1.19, 95% CI 1.08 to 1.31, P = 0.0004). However, remission rates were not significantly different (RR = 0.99, 95% CI: 0.84, 1.17).
  • Major Depressive Disorder (MDD): Cariprazine showed better MADRS scores compared to control groups (SMD = -0.12, 95% CI -0.19 to -0.04) and improved response rates (RR = 1.19, 95% CI 1.08 to 1.31). It also demonstrated a moderate effect size in reducing depressive symptoms.
  • Bipolar Depression: Cariprazine was effective in treating bipolar depression with standardized mean differences (SMDs) for depressive symptoms ranging from 0.41 to 0.16 and showed significant reductions in manic symptoms (SMD: -0.52). It was associated with higher remission (OR: 2.05) and response rates (OR: 2.31) for manic and mixed episodes.
  • Schizophrenia: Cariprazine was effective for acute psychosis in schizophrenia, with a Hedges' g of 0.40 (95% CI 0.32-0.49) and showed significant superiority over placebo for treating schizophrenia.
  • Cariprazine was associated with higher rates of adverse events compared to placebo, with common adverse events including akathisia, nausea, and extrapyramidal symptoms.
  • Cariprazine had a higher incidence of adverse events compared to other second-generation antipsychotics (SGAs) like brexpiprazole and aripiprazole, but its safety profile was comparable to lurasidone and brexpiprazole in terms of cardiovascular and metabolic parameters for schizophrenia.
  • Cariprazine showed a higher risk for akathisia compared to iloperidone, asenapine, and brexpiprazole, and while it caused less weight gain compared to olanzapine and quetiapine, the weight gain was still higher than with placebo.
  • There is no population types or subgroups information available in the reviewed studies.

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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