ASPOFAFF :: Journal - Volume 2 :: Volume 2 - Issue 1 :: Vol 2 - Iss 1 - Short Communication - Intramuscular Aripiprazole or Lorazepam versus Placebo for Agitation in Acure Mania


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ASPOFAFF :: Journal - Volume 2 :: Volume 2 - Issue 1 :: Vol 2 - Iss 1 - Short Communication - Intramuscular Aripiprazole or Lorazepam versus Placebo for Agitation in Acure Mania

Vol 2 - Iss 1 - Short Communication - Intramuscular Aripiprazole or Lorazepam versus Placebo for Agitation in Acure Mania #60

Intramuscular Aripiprazole or Lorazepam versus Placebo for Agitation in Acure Mania Dusan Kostic Ph.D 1, Dan Oren M.D 2, Taro Iwamoto Ph.D 3, Ronald Marcus M.D 4, Simon Vanveggel M.Sc 5, Robert McQuade Ph.D 6, Elyse Stock M.D 7. 1Bristol-Myers Squibb Company, PO Box 4000, Route 206 and Province Line Road, Lawrenceville, NJ 08453-4000, USA; Tel: (001) 609 252 5861; Fax: (001) 609 252 7605; E-mail: dusan.kostic@bms.com 2 Bristol-Myers Squibb Company, Wallingford, CT 3 Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan 4 Bristol-Myers Squibb Company, Wallingford, CT 5 Bristol-Myers Squibb Company, Braine-l’Alleud, Belgium 6 Otsuka America Pharmaceutical, Inc., Princeton, NJ 7 Bristol-Myers Squibb Company, Wallingford, CT Objective: A comparison of the efficacy of intramuscular (IM) aripiprazole and IM lorazepam with placebo in the treatment of acutely agitated patients with a manic or mixed episode in bipolar I disorder. Methods: This double-blinded, randomized, multicenter study compared two doses of IM aripiprazole (10 mg and 15 mg), lorazepam (2 mg), and placebo. Patients with acute agitation were screened for a minimum of 2 hours and baseline assessments made 1 hour before patients were given the initial injection. This was followed by inpatient evaluation for 24 hours. If needed, a second injection could be given at least 2 hours after the initial injection and a third injection, if needed, at least 2 hours after the second injection. The primary efficacy measure was mean change from baseline to 2 hours (LOCF), post-initial IM injection, in the PANSS Excited Component (PEC) score. Results: Mean changes from baseline in PEC scores 2 hours post-initial IM injection were aripiprazole 10 mg (n=75), –8.7; aripiprazole 15 mg (n=75), –8.7; lorazepam 2 mg (n=68), –9.6, placebo (n=73), –5.8 (all active drugs p<0.001 vs. placebo). Study medications were well tolerated: the majority of adverse events were mild or moderate in severity and no patients experienced serious adverse events related to study medication. Conclusion: Aripiprazole IM 10 mg and 15 mg shows significantly improved efficacy over placebo and similar to that of IM lorazepam 2 mg in the treatment of agitation in patients with bipolar I disorder, manic or mixed. Both IM aripiprazole and IM lorazepam were well tolerated in this study.

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