drugset

drugset / Trial / NCT00097266

Study of Aripiprazole in Patients With Acute Bipolar Mania

NCT00097266 ↗

Phase 3 Completed 615 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc. Otsuka America Pharmaceutical · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this research study is to confirm the safety and effectiveness of aripiprazole therapy over 12 weeks in subjects with bipolar disorder experiencing symptoms of mania.

Timeline

Start: 2004-12
Primary completion: 2007-01
Completion: 2007-01

Publications

Background Young AH, Oren DA, Lowy A, McQuade RD, Marcus RN, Carson WH, Spiller NH, Torbeyns AF, Sanchez R. Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study. Br J Psychiatry. 2009 Jan;194(1):40-8. doi: 10.1192/bjp.bp.108.049965.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aripiprazole	Other / unclassified	15 mg	Oral
Subject	Aripiprazole	Other / unclassified	30 mg	Oral
Comparator	Haloperidol	Other / unclassified	5 mg	Oral
Comparator	Haloperidol	Other / unclassified	15 mg	Oral

Indications