Efficacy and safety of aripiprazole in the treatment of bipolar disorder: a systematic review

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Abstract

Background

The current article is a systematic review concerning the efficacy and safety of aripiprazole in the treatment of bipolar disorder.

Methods

A systematic Medline and repositories search concerning the usefulness of aripiprazole in bipolar disorder was performed, with the combination of the words 'aripiprazole' and 'bipolar'.

Results

The search returned 184 articles and was last updated on 15 April 2009. An additional search included repositories of clinical trials and previous systematic reviews specifically in order to trace unpublished trials. There were seven placebo-controlled randomised controlled trials (RCTs), six with comparator studies and one with add-on studies. They assessed the usefulness of aripiprazole in acute mania, acute bipolar depression and during the maintenance phase in comparison to placebo, lithium or haloperidol.

Conclusion

Aripiprazole appears effective for the treatment and prophylaxis against mania. The data on bipolar depression are so far negative, however there is a need for further study at lower dosages. The most frequent adverse effects are extrapyramidal signs and symptoms, especially akathisia, without any significant weight gain, hyperprolactinaemia or laboratory test changes.

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Most cited references 121

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Lithium salts in the treatment of psychotic excitement.

Richard Cade (1949)

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Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors.

Terence E. Ryan, Frank Yocca, Tetsuro Kikuchi … (2002)

Aripiprazole is the first next-generation atypical antipsychotic with a mechanism of action that differs from currently marketed typical and atypical antipsychotics. Aripiprazole displays properties of an agonist and antagonist in animal models of dopaminergic hypoactivity and hyperactivity, respectively. This study examined the interactions of aripiprazole with a single population of human D2 receptors to clarify further its pharmacologic properties. In membranes prepared from Chinese hamster ovary cells that express recombinant D2L receptors, aripiprazole bound with high affinity to both the G protein-coupled and uncoupled states of receptors. Aripiprazole potently activated D2 receptor-mediated inhibition of cAMP accumulation. Partial receptor inactivation using the alkylating agent N-ethoxycarbonyl-2-ethoxy-1,2-dihydroquinoline (EEDQ) significantly reduced the maximum effect of aripiprazole on inhibition of cAMP accumulation. This effect was seen with concentrations of EEDQ that did not alter the maximal inhibitory effect of dopamine. Consistent with the expected effects of a partial agonist, increasing concentrations of aripiprazole blocked the action of dopamine with maximal blockade equal to the agonist effect of aripiprazole alone. The efficacy of aripiprazole relative to that of dopamine varied from 25% in cells that lacked spare receptors for dopamine to 90% in cells with receptor reserve. These results, together with previous studies demonstrating partial agonist activity at serotonin 5-hydroxytryptamine (5-HT)1A receptors and antagonist activity at 5-HT2A receptors, support the identification of aripiprazole as a dopamine-serotonin system stabilizer. The receptor activity profile may underlie the unique activity of aripiprazole in animals and its antipsychotic activity in humans.

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A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania.

Benjamin P. Keck, , Ronald Marcus … (2003)

The authors compared the efficacy and safety of aripiprazole, a novel antipsychotic, to placebo for treatment of patients in an acute manic or mixed episode of bipolar disorder. This 3-week, multicenter, double-blind study randomly assigned 262 bipolar disorder patients in an acute manic or mixed episode to aripiprazole, 30 mg/day (reduced to 15 mg/day if needed for tolerability), or placebo. Patients remained hospitalized for at least 2 of the weeks. The primary efficacy measure was mean change from baseline in total score on the Young Mania Rating Scale; response was defined as a decrease in score of > or =50%. Aripiprazole produced statistically significant mean improvements in total score on the Young Mania Rating Scale compared with placebo (-8.2 versus -3.4, respectively) and produced a significantly higher response rate (40% versus 19%). For key efficacy variables (response per Young Mania Rating Scale; Clinical Global Impression-Bipolar Version scores for severity of illness [mania] and change from preceding phase [mania]), aripiprazole separated from placebo by day 4. The completion rate was significantly higher with aripiprazole than with placebo (42% versus 21%). Discontinuations due to adverse events did not differ significantly between the aripiprazole and placebo groups. There were no significant changes in body weight versus placebo, and aripiprazole was not associated with elevated serum prolactin or QTc prolongation. Aripiprazole had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this randomized controlled trial.

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Author and article information

Journal

Journal ID (nlm-ta): Ann Gen Psychiatry

Title: Annals of General Psychiatry

Publisher: BioMed Central

ISSN (Electronic): 1744-859X

Publication date Collection: 2009

Publication date (Electronic): 27 July 2009

Volume: 8

Page: 16

Affiliations

[1 ]Third Department of Psychiatry, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece

[2 ]Bipolar Disorders Program, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain

Article

Publisher ID: 1744-859X-8-16

DOI: 10.1186/1744-859X-8-16

PMC ID: 2724509

PubMed ID: 19635147

SO-VID: cb62d440-1230-4728-879f-b3f79707786c

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Efficacy and safety of aripiprazole in the treatment of bipolar disorder: a systematic review

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Abstract

Background

Methods

Results

Conclusion

Related collections

Measurement of Glucocorticoid Receptor Signaling in Major Depression

Most cited references 121

Lithium salts in the treatment of psychotic excitement.

Aripiprazole, a novel antipsychotic, is a high-affinity partial agonist at human dopamine D2 receptors.

A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania.

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