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

December 18, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Multicenter, Randomized, Double-Blind, Parallel-Group Fixed-Dose Study of the Effect on Weight of Befeprunox Versus Olanzapine in the Treatment of Outpatients With Schizophrenia.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
      • Little Rock, Arkansas, United States, 72211
    • California
      • Anaheim, California, United States, 92802
      • Anaheim, California, United States, 92804
      • Anaheim, California, United States, 92805
      • Boynton Beach, California, United States, 33426
      • Costa Mesa, California, United States, 92363
      • Costa Mesa, California, United States, 92627
      • Escondido, California, United States, 92025
      • Garden Grove, California, United States, 92845
      • Glendale, California, United States, 91206
      • Huntington Beach, California, United States, 92648
      • La Mesa, California, United States, 91942
      • National City, California, United States, 91950
      • Oceanside, California, United States, 92056
      • Paramount, California, United States, 90723
      • Rosemead, California, United States, 91770
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92126
      • Santa Ana, California, United States, 92705
    • Connecticut
      • New Britain, Connecticut, United States, 06050
      • New London, Connecticut, United States, 06320
    • Florida
      • Deland, Florida, United States, 32720
      • Ft. Lauderdale, Florida, United States, 33319
      • Jacksonville, Florida, United States, 32256
      • North Miami, Florida, United States, 33161
      • St. Petersburg, Florida, United States, 33711
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Augusta, Georgia, United States, 30912
      • Marietta, Georgia, United States, 30060
    • Idaho
      • Coevr d'Alene, Idaho, United States, 83814
    • Illinois
      • Chicago, Illinois, United States, 60631
      • Hoffman Estates, Illinois, United States, 60194
      • Joliet, Illinois, United States, 60077
      • Naperville, Illinois, United States, 60540
    • Louisiana
      • Lake Charles, Louisiana, United States, 70601
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
    • Mississippi
      • Flowood, Mississippi, United States, 39232
    • Missouri
      • St. Louis, Missouri, United States, 63110
      • St. Louis, Missouri, United States, 63118
      • St. Louis, Missouri, United States, 63128
    • Nebraska
      • North Platte, Nebraska, United States, 69101
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
      • Clementon, New Jersey, United States, 08021
    • New York
      • New York, New York, United States, 10035
      • Rochester, New York, United States, 14624
      • Staten Island, New York, United States, 10312
    • North Carolina
      • Butner, North Carolina, United States, 27509
      • Chapel Hill, North Carolina, United States, 27599
      • Durham, North Carolina, United States, 27707
      • Morehead City, North Carolina, United States, 28557
    • North Dakota
      • Fargo, North Dakota, United States, 58102
    • Ohio
      • Cleveland, Ohio, United States, 44109
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73139
      • Oklahoma City, Oklahoma, United States, 73118
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
      • Philadelphia, Pennsylvania, United States, 19149
      • Pittsburgh, Pennsylvania, United States, 15108
    • Tennessee
      • Cordova, Tennessee, United States, 38018
      • Memphis, Tennessee, United States, 38105
      • Murfressboro, Tennessee, United States, 37129
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Austin, Texas, United States, 78756
      • DeSoto, Texas, United States, 75115
      • Irving, Texas, United States, 75062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Change from baseline on body weight at the final evaluation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 27, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3168A1-311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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