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Status:

COMPLETED

Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Schizophrenia

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

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...

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 stabl...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    July 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2007

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT00380224

    Start Date

    July 1 2006

    End Date

    September 1 2007

    Last Update

    December 27 2007

    Active Locations (67)

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    Page 1 of 17 (67 locations)

    1

    Little Rock, Arkansas, United States, 72201

    2

    Little Rock, Arkansas, United States, 72211

    3

    Anaheim, California, United States, 92802

    4

    Anaheim, California, United States, 92804