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Efficacy and Safety Study of Aripiprazole to Treat Schizophrenia

NCT00202007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-11-01

No results posted yet for this study

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

Interventions

DRUG

Aripiprazole tablet, 5-30mg/day, oral, 6 weeks

DRUG

Risperidone tablet, 1-6mg/day, oral, 6 weeks

Sponsors & Collaborators

  • Zhejiang Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Liang Shu, Professor · Institute of Mental Health, Peking University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Completion
2005-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202007 on ClinicalTrials.gov