Study to Evaluate the Efficacy, Safety, and Tolerability of Oral OPC-34712 and Aripiprazole for Treatment of Acute Schizophrenia (STEP 203)
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|ClinicalTrials.gov Identifier: NCT00905307|
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : September 3, 2015
Last Update Posted : October 20, 2015
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
459 participants recruited at 74 study centres in the United States, Asia and Europe.
Participants not responding adequately to treatment at Week 4 visit could continue in study and receive open-label OPC-34712 (starting dose 2.5 mg/day with option for decrease to 2 mg/day or increase to 3 mg/day) until Week 6 at study physician’s discretion.
Partipants were randomized in a 1:2:2:2:2:1 ratio to the following groups:
OPC-34712 0.25 mg arm, OPC-34712 low-dose, OPC-34712 mid-dose, OPC-34712 high-dose, Placebo, Aripiprazole. All other prohibited medications were discontinued at least 24 hours before the first dose of double-blind study medication.