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

• ClinicalTrials.gov Identifier: NCT00366704
• Recruitment Status: Terminated
• First Posted: August 21, 2006
• Last Update Posted: February 11, 2013
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborator: Solvay Pharmaceuticals
• Information provided by: Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: August 17, 2006
• First Posted Date: August 21, 2006
• Last Update Posted Date: February 11, 2013
• Study Start Date: November 2006
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2007): The primary analysis will be the change from baseline on body weight at the final evaluation. [ Time Frame: 8 weeks ]
• Original Primary Outcome Measures (submitted: August 18, 2006): The primary analysis will be the change from baseline on body weight at the final evaluation.
• Current Secondary Outcome Measures (submitted: December 21, 2007): 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. [ Time Frame: 8 weeks ]
• Original Secondary Outcome Measures (submitted: August 18, 2006): 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.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
• Official Title: 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.
• Brief Summary: The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Schizophrenia

Intervention

• Drug: bifeprunox
  .25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
• Drug: risperidone
  4mg, QD, 8 week treatment

Study Arms

• Experimental: A
  Intervention: Drug: bifeprunox
• Active Comparator: B
  Intervention: Drug: risperidone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Estimated Enrollment (submitted: August 18, 2006): 400
• Original Enrollment: Same as current
• Actual Study Completion Date: March 2008
• Actual Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00366704
• Other Study ID Numbers: 3168A1-313; B3101009 ( Other Identifier: Pfizer )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Solvay Pharmaceuticals

Investigators

• Study Director: Medical Monitor; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: April 2008