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Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
This study has been completed.
First Received: September 21, 2006   Last Updated: December 18, 2007   History of Changes
Sponsor: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00380224
  Purpose

This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.


Condition Intervention Phase
Schizophrenia
Drug: bifeprunox, olanzapine
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.

Resource links provided by NLM:


Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Change from baseline on body weight at the final evaluation.

Secondary Outcome Measures:
  • Change from baseline in triglyceride level; Change from baseline in waist circumference; and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.

Estimated Enrollment: 120
Study Start Date: July 2006
Study Completion Date: September 2007
Detailed Description:

This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

  Eligibility

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

Inclusion criteria:

  • Current treatment of at least 3 months with olanzapine.
  • Primary diagnosis of schizophrenia.
  • Total Positive and Negative Symptoms Scale (PANSS) score <=70 at screening and baseline.

Exclusion criteria:

  • Psychiatric diagnosis other than schizophrenia, as assessed by the modified Mini International Neuropsychiatric Interview (MINI), and considered by the investigator to be the primary psychiatric diagnosis.
  • History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
  • History of any suicide attempt within 3 years of day -1 or significant immediate risk of violence or suicidality.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380224

  Show 68 Study Locations
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

Study ID Numbers: 3168A1-311
Study First Received: September 21, 2006
Last Updated: December 18, 2007
ClinicalTrials.gov Identifier: NCT00380224     History of Changes
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Keywords provided by Wyeth:
schizophrenia

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

ClinicalTrials.gov processed this record on February 08, 2010