Research article summary (published 30 Mar 2007):

Management of acute agitation in patients with bipolar disorder: efficacy and safety of intramuscular aripiprazole.

Full Abstract

To investigate the efficacy and safety of intramuscular (IM) aripiprazole for the treatment of agitation in patients with bipolar I disorder, manic or mixed episodes. In total, 301 patients experiencing acute agitation were randomized to IM aripiprazole 9.75 mg per injection (n = 78), IM aripiprazole 15 mg per injection (n = 78), IM lorazepam 2 mg per injection (n = 70), or IM placebo (n = 75) in this double-blind multicenter study. Patients could receive up to 3 injections over 24 hours. Primary efficacy measure was mean change in Positive and Negative Syndrome Scale Excited Component score from baseline at 2 hours after first injection. Mean improvements in Positive and Negative Syndrome Scale Excited Component score at 2 hours were significantly greater with IM aripiprazole (9.75 mg, -8.7; 15 mg, -8.7) and IM lorazepam (-9.6) versus IM placebo (-5.8; P <or= 0.001). For all other efficacy measures, all 3 active treatments showed significantly greater improvements over IM placebo at 2 hours (P < 0.05), with similar improvements across the active treatments. Significant differences over IM placebo were seen by 45 to 60 minutes for several efficacy parameters. Both IM aripiprazole doses were well tolerated; the safety profile was similar to oral aripiprazole. Oversedation (Agitation-Calmness Evaluation Scale score of 8 or 9) during 2 hours after first injection was less frequent with IM aripiprazole 9.75 mg (6.7%) and IM placebo (6.8%) versus IM aripiprazole 15 mg (17.3%) and IM lorazepam (19.1%). IM aripiprazole 9.75 and 15 mg are effective and well tolerated for acute agitation in bipolar disorder, although the low incidence of oversedation suggests a risk-benefit profile for IM aripiprazole 9.75 mg.

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Author information

Author/s: Zimbroff, Dan L (DL); Marcus, Ronald N (RN); Manos, George (G); Stock, Elyse (E); McQuade, Robert D (RD); Auby, Philippe (P); Oren, Dan A (DA);

Affiliation: Pacific Clinical Research Medical Group, Upland, CA 91786, USA. dan.zimbroff(-atsign-)pcrmg.com

Journal and publication information

Publication Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: Journal of clinical psychopharmacology (J Clin Psychopharmacol), published in United States. (Language: eng)

Reference: 2007-Apr; vol 27 (issue 2) : pp 171-6

Dates: Created 2007/04/06; Completed 2007/07/30;

PMID: 17414241, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Acute Disease Adult Anti-Anxiety Agents - administration & dosage; adverse effects; therapeutic use Antipsychotic Agents - administration & dosage; adverse effects; therapeutic use Bipolar Disorder - complications; drug therapy Disorders of Excessive Somnolence - chemically induced Dizziness - chemically induced Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Headache - chemically induced

Humans Injections, Intramuscular Lorazepam - administration & dosage; adverse effects; therapeutic use Male Nausea - chemically induced Patient Dropouts - statistics & numerical data Piperazines - administration & dosage; adverse effects; therapeutic use Psychomotor Agitation - complications; drug therapy Quinolones - administration & dosage; adverse effects; therapeutic use Sleep Initiation and Maintenance Disorders - chemically induced Treatment Outcome Vomiting - chemically induced

Associated Chemicals: Anti-Anxiety Agents (0) ; Antipsychotic Agents (0) ; Piperazines (0) ; Quinolones (0) ; aripiprazole (129722-12-9) ; Lorazepam (846-49-1)

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