Aripiprazole

(Abilify Maintena®)

Abilify Maintena®

Drug updated on 11/1/2024

Dosage FormInjection (intramuscular; 300 mg and 400 mg)
Drug ClassAtypical antipsychotics
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for treatment of schizophrenia in adults
  • Indicated for maintenance monotherapy treatment of bipolar I disorder in adults.

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Summary
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  • This summary is based on the review of 15 systematic review(s)/meta-analysis(es). [1-15]
  • Youth with Bipolar Disorder Type I: Aripiprazole demonstrated significant effectiveness in reducing manic symptoms (SMD (standardized mean difference) = -0.67, 95% CI = -0.33, -1.01) and increased mania response rates (RR (relative risk) = 2.05, 95% CI (confidence interval) = 1.44, 2.92). Risperidone showed the highest efficacy in manic symptom reduction (SMD = -1.18) and mania response (RR = 2.58), with other SGAs (second-generation antipsychotics) showing similar trends.
  • Schizophrenia Spectrum Disorders (General Population): Aripiprazole was effective in dual LAI AP (Long-acting injectables antipsychotics) treatments, particularly in combination with paliperidone palmitate, for treatment-resistant schizophrenia, with no new or unexpected adverse events reported.
  • Acute Schizophrenia Symptoms: Aripiprazole LAI reduced symptoms more effectively than placebo (SMD = -0.64, 95% CI = -0.80, -0.48). Other LAIs such as olanzapine, risperidone, and paliperidone also demonstrated significant symptom reduction, with comparable effectiveness across these treatments.
  • Rapid Cycling Bipolar Disorder: Aripiprazole showed notable benefits in reducing mania symptoms (g = 1.09), while quetiapine and olanzapine also presented significant reductions in mania symptoms in this population.
  • Youth with Bipolar Disorder Type I: Aripiprazole was associated with increased risks of sedation, weight gain, and metabolic issues compared to placebo and mood stabilizers, with similar safety concerns observed across other SGAs.
  • Adults with Schizophrenia or Schizoaffective Disorder: Aripiprazole demonstrated a lower risk of treatment discontinuation due to adverse events compared to other LAIs, though it had a higher risk of treatment-emergent adverse events than most other LAIs.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Abilify Maintena (aripiprazole) Prescribing Information.2020Otsuka America Pharmaceutical, Inc., Princeton, NJ

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systematic Review and Network Meta-Analysis: Efficacy and Safety of Antipsychotics vs Antiepileptics or Lithium for Acute Mania in Children and Adolescents2024Journal of the American Academy of Child and Adolescent Psychiatry
Combination of Two Long-Acting Antipsychotics in Schizophrenia Spectrum Disorders: A Systematic Review2024Brain Sciences
Long-Acting Injectable Second-Generation Antipsychotics vs Placebo and Their Oral Formulations in Acute Schizophrenia: A Systematic Review and Meta-Analysis of Randomized-Controlled-Trials2024Schizophrenia Bulletin
Comparative Safety of Long-Acting Injectable Antipsychotics: A Systematic Review and Network Meta-Analysis2023Psychiatry Investigation
Evidence-Based Recommendations for the Pharmacological Treatment of Women with Schizophrenia Spectrum Disorders2023Current Psychiatry Reports
Antipsychotic dose, dopamine D2 receptor occupancy and extrapyramidal side-effects: a systematic review and dose-response meta-analysis2023Molecular Psychiatry
What Role for Long-Acting Injectable Antipsychotics in Managing Schizophrenia Spectrum Disorders in Children and Adolescents? A Systematic Review2023Paediatric Drugs
Therapeutic Reference Range for Aripiprazole in Schizophrenia Revised: a Systematic Review and Metaanalysis2022Psychopharmacology
Pharmacological treatment strategies for antipsychotic-induced hyperprolactinemia: a systematic review and network meta-analysis2022Translational Psychiatry
A systematic review and meta-analysis of treatments for rapid cycling bipolar disorder2022Acta Psychiatrica Scandinavica
Long-acting injectable antipsychotics for early psychosis: A comprehensive systematic review2022Plos One
Antipsychotic-Induced Weight Gain: Dose-Response Meta-Analysis of Randomized Controlled Trials2022Schizophrenia Bulletin
Preventing new episodes of bipolar disorder in adults: Systematic review and meta-analysis of randomized controlled trials2022European Neuropsychopharmacology : the Journal of the European College of
Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia2020The American Journal of Psychiatry
Economic evaluations on the use of aripiprazole for patients with schizophrenia: A systematic review2020Journal of Clinical Pharmacy and Therapeutics

Clinical Practice Guidelines