Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Aripiprazole

• Registration Number: NCT00080327
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary

A study to evaluate three doses of aripiprazole versus placebo in patients with an acute episode of schizophrenia

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-03-26
• Study First Submitted QC: 2004-03-29
• Study First Posted: 2004-03-30
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Status Verified: 2008-08
• Last Update Submitted: 2013-11-07
• Last Update Posted: 2013-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

• Men and women, ages 18 and older, with a worsening of schizophrenia symptoms over the past three months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Placebo	-
1	Aripiprazole	-
2	Aripiprazole	-
3	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Change at endpoint in schizophrenia rating scale

Secondary Outcome Measures

Name	Time	Method
Clinical Global Improvement scale at endpoint and time to response

Trial Locations

Locations (1)

Bristol-Meyers Squibb Call Center; 🇺🇸 Wallingford, Connecticut, United States