drugset / Trial / NCT00202007
Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia
Phase 2
Completed
240 enrolled
Otsuka Beijing Research Institute
Zhejiang Otsuka Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2005-02
- Primary completion
- —
- Completion
- 2005-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aripiprazole | Other / unclassified | 5 mg | Oral |
| Subject | Aripiprazole | Other / unclassified | 30 mg | Oral |
| Subject | Risperidone | Other / unclassified | 1 mg | Oral |
| Subject | Risperidone | Other / unclassified | 6 mg | Oral |