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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00265551
First received: December 12, 2005
Last updated: December 7, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: SCA-136 (200 mg)
Drug: SCA-136 (400 mg)
Drug: olanzapine (15 mg)
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Change from baseline to day 42 on the positive subscale of the SCI-PANNS

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: January 2006
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265551

  Show 35 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00265551     History of Changes
Other Study ID Numbers: 3153A1-202
Study First Received: December 12, 2005
Last Updated: December 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents

ClinicalTrials.gov processed this record on September 22, 2014