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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
History of Changes
  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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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
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

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
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 17, 2013