Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.

NCT ID: NCT00380224

Last Updated: 2007-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine), with respect to the affect on weight during the treatment of outpatients with schizophrenia. The study will compare the effect of these medications on several variables, including body weight and triglyceride levels.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the treatment of outpatients with schizophrenia, with olanzapine as the active comparator. Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There will be 2 treatment arms in this study, approximately 60 subjects per arm. After randomization and blinding, each subject will either remain on olanzapine or switch to bifeprunox. Assessments, including body weight and waist measurements, will be made at each study visit.Subjects will participate in the study for approximately 11 weeks. After a screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who do not enter the long-term extension will return for a follow-up visit 7 days after discontinuing the use of test article. Subjects who do enter the long-term extension will have a 7-day taper/titration period after the 8 weeks of double-blind treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

bifeprunox, olanzapine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Current treatment of at least 3 months with olanzapine.
* Primary diagnosis of schizophrenia.
* Total Positive and Negative Symptoms Scale (PANSS) score \<=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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Little Rock, Arkansas, United States

Site Status

Little Rock, Arkansas, United States

Site Status

Anaheim, California, United States

Site Status

Anaheim, California, United States

Site Status

Anaheim, California, United States

Site Status

Boynton Beach, California, United States

Site Status

Costa Mesa, California, United States

Site Status

Costa Mesa, California, United States

Site Status

Escondido, California, United States

Site Status

Garden Grove, California, United States

Site Status

Glendale, California, United States

Site Status

Huntington Beach, California, United States

Site Status

La Mesa, California, United States

Site Status

National City, California, United States

Site Status

Oceanside, California, United States

Site Status

Paramount, California, United States

Site Status

Rosemead, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

San Diego, California, United States

Site Status

Santa Ana, California, United States

Site Status

New Britain, Connecticut, United States

Site Status

New London, Connecticut, United States

Site Status

DeLand, Florida, United States

Site Status

Fort Lauderdale, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

North Miami, Florida, United States

Site Status

St. Petersburg, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Augusta, Georgia, United States

Site Status

Marietta, Georgia, United States

Site Status

Coevr d'Alene, Idaho, United States

Site Status

Chicago, Illinois, United States

Site Status

Hoffman Estates, Illinois, United States

Site Status

Joliet, Illinois, United States

Site Status

Naperville, Illinois, United States

Site Status

Lake Charles, Louisiana, United States

Site Status

Gaithersburg, Maryland, United States

Site Status

Worcester, Massachusetts, United States

Site Status

Flowood, Mississippi, United States

Site Status

St Louis, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

St Louis, Missouri, United States

Site Status

North Platte, Nebraska, United States

Site Status

Cherry Hill, New Jersey, United States

Site Status

Clementon, New Jersey, United States

Site Status

New York, New York, United States

Site Status

Rochester, New York, United States

Site Status

Staten Island, New York, United States

Site Status

Butner, North Carolina, United States

Site Status

Chapel Hill, North Carolina, United States

Site Status

Durham, North Carolina, United States

Site Status

Morehead City, North Carolina, United States

Site Status

Fargo, North Dakota, United States

Site Status

Cleveland, Ohio, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Oklahoma City, Oklahoma, United States

Site Status

Norristown, Pennsylvania, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Cordova, Tennessee, United States

Site Status

Memphis, Tennessee, United States

Site Status

Murfressboro, Tennessee, United States

Site Status

Nashville, Tennessee, United States

Site Status

Austin, Texas, United States

Site Status

DeSoto, Texas, United States

Site Status

Irving, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3168A1-311

Identifier Type: -

Identifier Source: org_study_id