Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

Phase 2

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00265551
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-14
• Study Start: 2006-01
• Study Completion: 2007-01
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-07
• Last Update Posted: 2007-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinical diagnosis of schizophrenia
• Ability to remain hospitalized for at least first 4 weeks of study
• Needs hospitalization due to worsening of schizophrenia

Exclusion Criteria

• Type 1 or 2 diabetes
• Previous use of clozapine
• Serious medical illness other than schizophrenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline to day 42 on the positive subscale of the SCI-PANNS

Secondary Outcome Measures

Name	Time	Method
Change from baseline to day 42 on:
SCI-PANNS total score
negative symptom sub-scale score of SCI-PANNS
general psychopathology subscale score of SCI-PANNS
response rate based upon SCI-PANNS total score
BPRS score
CGI-S score
CGI-I score
Cognitive assessments scores