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

Schizophrenia Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00366704
• Other study ID #: 3168A1-313
• Secondary ID: B3101009
• Status: Terminated
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: February 7, 2013
• Start date: November 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosColombia: Institutional Review BoardPeru: General Directorate of Pharmaceuticals, Devices, and DrugsUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary analysis will be the change from baseline on body weight at the final evaluation.		8 weeks	Yes
Secondary	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	Yes