Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint - Full Text View

Sponsors and Collaborators:	Wyeth Solvay Pharmaceuticals
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00366704

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: bifeprunox Drug: risperidone	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Bifeprunox Bifeprunox mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
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.

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary analysis will be the change from baseline on body weight at the final evaluation. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	November 2006
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: bifeprunox .25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
B: Active Comparator	Drug: risperidone 4mg, QD, 8 week treatment

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366704

Show 66 Study Locations

Sponsors and Collaborators

Wyeth

Solvay Pharmaceuticals

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3168A1-313
Study First Received:	August 17, 2006
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00366704
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Colombia: Institutional Review Board; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; United States: Food and Drug Administration

Keywords provided by Wyeth:

Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Body Weight
Dopamine
Mental Disorders

Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009