Aripiprazole

(Abilify Maintena®)

Abilify Maintena®

Drug updated on 5/17/2024

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.

Summary
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  • Aripiprazole (Abilify Maintena) is indicated for the treatment of schizophrenia and maintenance monotherapy treatment of bipolar I disorder in adults. It has demonstrated effectiveness in treating acute bipolar manic episodes in youth, showing better tolerability compared to risperidone and olanzapine, but with less efficacy at higher doses.
  • The analysis derived from 23 systematic reviews/meta-analyses on aripiprazole's efficacy, safety, tolerability, and considerations across various populations including children/adolescents and adults with schizophrenia or bipolar disorder.
  • In young people experiencing early psychosis, aripiprazole led to significant weight gain, which suggests the need for close monitoring of metabolic side effects within this population group.
  • For adult patients suffering from schizophrenia or bipolar disorder, aripiprazole showed high effectiveness as both an antipsychotic addressing positive/negative symptoms of schizophrenia, as well as a mood stabilizer. However, impulsive/compulsive behaviors were noted side effects that require attention.
  • Among second-generation antipsychotics (SGAs), it displayed the highest effectiveness for managing conditions like bipolar mania and Tourette's Disorder, while its long-term use via injectable form significantly lowered the risk of discontinuation due to adverse events, indicating a favorable safety profile, especially among those diagnosed with chronic disorders such as schizoaffective disease/schizophrenia.
  • Specific side effects include dose-dependent weight gain/metabolic disturbances, although comparatively lesser than other drugs like olanzapine; also, unlike risperidone/paliperidone/olanzapine which increased prolactin levels leading potentially harmful implications, particularly among younger users - aripiprazole actually decreased these levels, thereby reducing associated risks considerably.
  • Comparative studies suggest that personalized dosing strategies might offer more benefits without significantly increasing adverse effects, making it an important consideration. Moreover, consistent response/improvement rates coupled with lower all-cause discontinuation rates make it more acceptable than a placebo.
  • Aripiprazole's transdiagnostic efficacy across various disorders, meeting criteria for treatment across multiple DSM-5 diagnostic groups with a specific dose-response relationship, makes it a valuable option in the long-term management of schizophrenia and bipolar disorders.

Product Monograph / Prescribing Information

Document TitleYearSource
Abilify Maintena (aripiprazole) Prescribing Information.2020Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A systematic review and network meta-analysis on comparative efficacy, acceptability, and safety of treatments in acute bipolar mania in youths.2024Journal of Affective Disorders
Aripiprazole and its adverse effects in the form of impulsive-compulsive behaviors: a systematic review of case reports.2024Psychopharmacology
Effectiveness and safety of second-generation antipsychotics for psychiatric disorders apart from schizophrenia: a systematic review and meta-analysis.2024Psychiatry Research
Comparative safety of long-acting injectable antipsychotics: a systematic review and network meta-analysis.2023Psychiatry Investigation
Comparative effects of 11 antipsychotics on weight gain and metabolic function in patients with acute schizophrenia: a dose-response meta-analysis.2023The Journal of Clinical Psychiatry
Comparison of antipsychotic dose equivalents for acute bipolar mania and schizophrenia.2023BMJ Mental Health
What role for long-acting injectable antipsychotics in managing schizophrenia spectrum disorders in children and adolescents? a systematic review.2023Paediatric Drugs
Aripiprazole in young people with early psychosis: a systematic review and meta-analysis of weight gain.2022Australasian Psychiatry
Antipsychotic-induced weight gain: dose-response meta-analysis of randomized controlled trials.2022Schizophrenia Bulletin
A meta-analysis of antipsychotic-induced hypo- and hyperprolactinemia in children and adolescents.2022Journal of Child and Adolescent Psychopharmacology
A systematic review and meta-analysis of treatments for rapid cycling bipolar disorder.2022Acta Psychiatrica Scandinavica
Long-acting injectable antipsychotics for early psychosis: a comprehensive systematic review.2022PLoS One
Pharmacological treatment for bipolar mania: a systematic review and network meta-analysis of double-blind randomized controlled trials.2022Molecular Psychiatry
Therapeutic reference range for aripiprazole in schizophrenia revised: a systematic review and metaanalysis.2022Psychopharmacology
Dose-dependent efficacy of aripiprazole in treating patients with schizophrenia or schizoaffective disorder: a systematic review and meta-analysis of randomized controlled trials.2021Frontiers in Psychiatry
Long-term efficacy and tolerability of adjunctive aripiprazole for major depressive disorder: systematic review and meta-analysis.2021The Primary Care Companion For CNS Disorders
Efficacy and tolerability of aripiprazole versus D2 antagonists in the early course of schizophrenia: a systematic review and meta-analysis.2021NPJ schizophrenia
Efficacy and tolerability of atypical antipsychotics for acute bipolar depression: a network meta-analysis.2021BMC psychiatry
Aripiprazole monotherapy as transdiagnostic intervention for the treatment of mental disorders: an umbrella review according to TRANSD criteria.2020European Neuropsychopharmacology
New developments in the use of atypical antipsychotics in the treatment of bipolar disorder: a systematic review of recent randomized controlled trials.2020Current Psychiatry Reports
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.2020The American Journal of Psychiatry
Aripiprazole vs. brexpiprazole for acute schizophrenia: a systematic review and network meta-analysis.2020Psychopharmacology

Clinical Practice Guidelines