Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

A Multicenter, Randomized, Double-blind, Parallel-group Fixed-dose Study of the Effect on Weight of Bifeprunox Versus Risperidone in the Treatment of Outpatients With Schizophrenia.

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: bifeprunox; Drug: risperidone

• Study Type: Interventional
• Enrollment (Anticipated): 400
• 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, 92701
    • Santa Ana, California, United States, 92705
  • Connecticut
    • New London, Connecticut, United States, 06320
  • Florida
    • 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, 30307
    • 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
    • Pittsfield, Massachusetts, United States, 01201
    • 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
    • Rochester, New York, United States, 14624
    • Staten Island, New York, United States, 10312
  • North Carolina
    • Butner, North Carolina, United States, 27509
    • Morehead City, North Carolina, United States, 28557
  • Ohio
    • Beachwood, Ohio, United States, 44122
    • Cleveland, Ohio, United States, 44109
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73139
  • Pennsylvania
    • East Stroudsberg, Pennsylvania, United States, 18301
    • Jenkintown, Pennsylvania, United States, 19046
    • 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
    • Memphis, Tennessee, United States, 38157
  • Texas
    • Austin, Texas, United States, 78756
    • DeSoto, Texas, United States, 75115
    • Irving, Texas, United States, 75062
    • San Antonio, Texas, United States, 78229

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 risperidone.
• Primary diagnosis of schizophrenia.
• Total Positive and Negative Symptoms Scale (PANSS) score < or = 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: risperidone; 4mg, QD, 8 week treatment
Experimental: A	Drug: bifeprunox; .25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary analysis will be the change from baseline on body weight at the final evaluation.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary outcomes include: 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.	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 18, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): February 11, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: April 1, 2008

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; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: 3168A1-313; B3101009 (Other Identifier: Pfizer)