NCT00202007

Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

A Multi-Center, Randomized, Double-Blind Study, Comparing With Risperidone, to Evaluate the Efficacy and Safety of Aripiprazole in the Treatment of Patients With Schizophrenia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study design is subject to relevant SFDA regulations about clinical trials. Patients will be screened for inclusion into the study at the initial visit(240 patients to be recruited) and then undergo a minimum of 3-7 day's placebo washout period(placebo wash out is to eliminate the effect of prior antipsychotic medication with tablets without any active ingredients)(patients without prior antipsychotic medication are exempt from the washout phase). After screening and washout period, eligible patients will be randomly assigned to the two treatment group, Aripiprazole or Risperidone, for 6 week's treatment. Patients will be hospitalized for the entire duration of the study. Patients' condition will be assessed weekly.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Aripiprazole tablet, 5-30mg/day, oral, 6 weeks
DRUG	Risperidone tablet, 1-6mg/day, oral, 6 weeks

Timeline

• Start date: 2005-02-01
• Completion: 2005-07-01
• First posted: 2005-09-20
• Last updated: 2023-11-01

Locations

6 sites across 1 country: China