Study of Alternate Formulation of Aripiprazole in Agitated Patients With Schizophrenic Disorders

NCT00036127 ↗

Phase 2/3 Completed Otsuka Pharmaceutical Development & Commercialization, Inc.

Treatment

Summary

Study to learn if the alternate formulation is effective in agitated schizophrenic patients

Timeline

Start: 2002-04
Primary completion: 2003-01
Completion: 2003-01

Outcome

Met primary endpoint

paper Intramuscular aripiprazole 5.25 mg, 9.75 mg, and 15 mg and IM haloperidol 7.5 mg demonstrated significantly greater reduction in the primary efficacy measure versus placebo. PMID 17284138 ↗

Publications

Tran-Johnson TK, Sack DA, Marcus RN, Auby P, McQuade RD, Oren DA. Efficacy and safety of intramuscular aripiprazole in patients with acute agitation: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2007 Jan;68(1):111-9. doi: 10.4088/jcp.v68n0115.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	1 mg	Intramuscular
Subject	Aripiprazole	Other / unclassified	5.25 mg	Intramuscular
Subject	Aripiprazole	Other / unclassified	9.75 mg	Intramuscular
Subject	Aripiprazole	Other / unclassified	15 mg	Intramuscular