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A Systematic Review and Meta-analysis of Randomized Controlled Trials

Harald Scherk, MD; Frank Gerald Pajonk, MD, PhD; Stefan Leucht, MD, PhD

Arch Gen Psychiatry. 2007;64(4):442-455.

Context  Recommendations of treatment guidelines concerning the use of second-generation antipsychotic (SGA) agents for acute mania vary substantially across committees or working groups. Meta-analyses addressing the use of SGAs in the treatment of acute mania are lacking.

Objective  To conduct a meta-analysis of the efficacy and safety of SGAs in the treatment of acute mania.

Data Sources  Randomized controlled trials comparing SGAs with placebo, first-generation antipsychotic drugs, or mood stabilizers (MSs) in the treatment of acute mania were searched for in the PsiTri and MEDLINE databases (last search: May 2006).

Study Selection  The abstracts, titles, and index terms of studies were searched using the following key words: aripiprazole, amisulpride, clozapine, olanzapine, quetiapine, risperidone, ziprasidone, and zotepine in conjunction with mania, manic, and bipolar.

Data Extraction  Data on efficacy, global dropout, dropout due to adverse events, dropout due to inefficacy, weight gain, rate of somnolence, and extrapyramidal symptoms were extracted and combined in a meta-analysis.

Data Synthesis  A total of 24 studies with 6187 patients were included. The SGAs were significantly more efficacious than placebo. The analysis demonstrated that adding antipsychotic agents to MS treatment was significantly more effective than treatment with MSs alone. The SGAs displayed efficacy comparable with that of MSs. Some SGAs seemed to induce more extrapyramidal symptoms than placebo. The SGAs were also associated with higher rates of somnolence than placebo.

Conclusion  Currently available data suggest that combining SGAs and MSs is the most efficacious treatment of acute mania.

Author Affiliations: Department of Psychiatry and Psychotherapy, Georg-August University Goettingen, Goettingen (Dr Scherk), Center for Psychiatric and Psychotherapeutic Care and Rehabilitation, Dr K. Fontheim's Hospital for Mental Health, Liebenburg (Dr Pajonk), and Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar der Technischen Universität München, Munich (Dr Leucht), Germany.

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