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

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.

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: bifeprunox, olanzapine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
    • Little Rock, Arkansas, United States, 72211
  • California
    • Anaheim, California, United States, 92802
    • Anaheim, California, United States, 92804
    • Anaheim, California, United States, 92805
    • Boynton Beach, California, United States, 33426
    • Costa Mesa, California, United States, 92363
    • Costa Mesa, California, United States, 92627
    • Escondido, California, United States, 92025
    • Garden Grove, California, United States, 92845
    • Glendale, California, United States, 91206
    • Huntington Beach, California, United States, 92648
    • La Mesa, California, United States, 91942
    • National City, California, United States, 91950
    • Oceanside, California, United States, 92056
    • Paramount, California, United States, 90723
    • Rosemead, California, United States, 91770
    • San Diego, California, United States, 92108
    • San Diego, California, United States, 92123
    • San Diego, California, United States, 92126
    • Santa Ana, California, United States, 92705
  • Connecticut
    • New Britain, Connecticut, United States, 06050
    • New London, Connecticut, United States, 06320
  • Florida
    • Deland, Florida, United States, 32720
    • Ft. Lauderdale, Florida, United States, 33319
    • Jacksonville, Florida, United States, 32256
    • North Miami, Florida, United States, 33161
    • St. Petersburg, Florida, United States, 33711
  • Georgia
    • Atlanta, Georgia, United States, 30308
    • Augusta, Georgia, United States, 30912
    • Marietta, Georgia, United States, 30060
  • Idaho
    • Coevr d'Alene, Idaho, United States, 83814
  • Illinois
    • Chicago, Illinois, United States, 60631
    • Hoffman Estates, Illinois, United States, 60194
    • Joliet, Illinois, United States, 60077
    • Naperville, Illinois, United States, 60540
  • Louisiana
    • Lake Charles, Louisiana, United States, 70601
  • Maryland
    • Gaithersburg, Maryland, United States, 20877
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
  • Mississippi
    • Flowood, Mississippi, United States, 39232
  • Missouri
    • St. Louis, Missouri, United States, 63110
    • St. Louis, Missouri, United States, 63118
    • St. Louis, Missouri, United States, 63128
  • Nebraska
    • North Platte, Nebraska, United States, 69101
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
    • Clementon, New Jersey, United States, 08021
  • New York
    • New York, New York, United States, 10035
    • Rochester, New York, United States, 14624
    • Staten Island, New York, United States, 10312
  • North Carolina
    • Butner, North Carolina, United States, 27509
    • Chapel Hill, North Carolina, United States, 27599
    • Durham, North Carolina, United States, 27707
    • Morehead City, North Carolina, United States, 28557
  • North Dakota
    • Fargo, North Dakota, United States, 58102
  • Ohio
    • Cleveland, Ohio, United States, 44109
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73139
    • Oklahoma City, Oklahoma, United States, 73118
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19401
    • Philadelphia, Pennsylvania, United States, 19149
    • Pittsburgh, Pennsylvania, United States, 15108
  • Tennessee
    • Cordova, Tennessee, United States, 38018
    • Memphis, Tennessee, United States, 38105
    • Murfressboro, Tennessee, United States, 37129
    • Nashville, Tennessee, United States, 37212
  • Texas
    • Austin, Texas, United States, 78756
    • DeSoto, Texas, United States, 75115
    • Irving, Texas, United States, 75062

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

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 on body weight at the final evaluation.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 21, 2006
• First Submitted That Met QC Criteria: September 21, 2006
• First Posted (Estimate): September 25, 2006

Study Record Updates

• Last Update Posted (Estimate): December 27, 2007
• Last Update Submitted That Met QC Criteria: December 18, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: schizophrenia
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: 3168A1-311