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

December 7, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Randomized, Double-Blind, Placebo-Controlled, Olanzapine-Referenced, Parallel Group Safety, Efficacy, and Tolerability Study of SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
    • California
      • Cerritos, California, United States, 90703
      • Costa Mesa, California, United States, 92627
      • La Mesa, California, United States, 91942
      • Oceanside, California, United States, 92056
      • Paramount, California, United States, 90723
      • Pico Rivera, California, United States, 90660
      • Rosemead, California, United States, 91770
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92123
      • Torrance, California, United States, 90502
    • Connecticut
      • Middletown, Connecticut, United States, 06457
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
    • Florida
      • Fort Lauderdale, Florida, United States, 33301
      • Kissimmee, Florida, United States, 34741
      • North Miami, Florida, United States, 33161
    • Illinois
      • Hoffman Estates, Illinois, United States, 60194
    • Indiana
      • Indianapolis, Indiana, United States, 46222
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
    • Maryland
      • Baltimore, Maryland, United States, 21202
      • Rockville, Maryland, United States, 20850
    • Missouri
      • St. Louis, Missouri, United States, 63118
    • New Jersey
      • Willingboro, New Jersey, United States, 08046
    • New York
      • Cedarhurst, New York, United States, 11516
      • Holliswood, New York, United States, 11423
    • Ohio
      • Chagrin Falls, Ohio, United States, 44022
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45267
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
    • Tennessee
      • Memphis, Tennessee, United States, 38117
    • Texas
      • Austin, Texas, United States, 78756
      • Austin, Texas, United States, 78729
      • DeSoto, Texas, United States, 75115
    • Washington
      • Tacoma, Washington, United States, 98493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline to day 42 on the positive subscale of the SCI-PANNS

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 14, 2005

Study Record Updates

Last Update Posted (Estimate)

December 10, 2007

Last Update Submitted That Met QC Criteria

December 7, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3153A1-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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