Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients - Full Text View

Sponsors and Collaborators:	Solvay Pharmaceuticals H. Lundbeck A/S Wyeth
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00396214

Purpose

The primary objective of the study is to evaluate changes in weight short and long term with bifeprunox and quetiapine. Study participation for the subject is 57 weeks.

Condition	Intervention	Phase
Schizophrenia	Drug: Bifeprunox Drug: Quetiapine	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate 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/Efficacy Study
Official Title:	A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline in Triglyceride [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Detorioration (composite definition using PANSS total score and CGI-I) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Change from baseline in Weight, Triglyceride and Cardiovascular risk factors [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment:	83
Study Start Date:	April 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Bifeprunox 52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 1 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
2: Experimental	Drug: Bifeprunox 52 weeks of fixed oral doses of bifeprunox at 30 mg/day administered as a single dose with 2 week upward titration from 0.25 mg/day dose. Placebo will be used for evening dose.
3: Active Comparator	Drug: Quetiapine Fixed oral dose of quetiapine at 400 mg/day to be administered in divided doses (BID) utilizing a 5-day upward titration from 50 mg/day.

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of Schizophrenia
18-65 years
No hospitalization for an exacerbation of schizophrenia within two months prior to screening and during the screening period

Exclusion Criteria:

Subjects who are acutely psychotic or subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
At significant risk of suicide, and the potential for violent behavior (likely to harm themselves or others) based on history

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396214

Show 151 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

H. Lundbeck A/S

Wyeth

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Loretta Stallings )
Study ID Numbers:	S154.3.021, 2006-004973-83
Study First Received:	November 3, 2006
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00396214
Health Authority:	United States: Food and Drug Administration; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Slovakia: State Institute for Drug Control

Keywords provided by Solvay Pharmaceuticals:

Schizophrenia
weight changes

Study placed in the following topic categories:

Schizophrenia
Body Weight
Signs and Symptoms
Quetiapine

Mental Disorders
Body Weight Changes
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009