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SchizophreniaPhase 3NCT00380224

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

A Phase 3 study testing bifeprunox, olanzapine in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 67 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
bifeprunox, olanzapine
How many people
120 participants
Where
67 sitesUnited States
Study dates
Jul 2006to Sep 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Study site

    Anaheim, California, 92802

  • Study site

    Anaheim, California, 92804

  • Study site

    Anaheim, California, 92805

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Augusta, Georgia, 30912

  • Study site

    Austin, Texas, 78756

  • Study site

    Boynton Beach, California, 33426

  • Study site

    Butner, North Carolina, 27509

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Cherry Hill, New Jersey, 08002

  • Study site

    Chicago, Illinois, 60631

  • Study site

    Clementon, New Jersey, 08021

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Coevr d'Alene, Idaho, 83814

  • Study site

    Cordova, Tennessee, 38018

  • Study site

    Costa Mesa, California, 92363

  • Study site

    Costa Mesa, California, 92627

  • Study site

    DeLand, Florida, 32720

  • Study site

    DeSoto, Texas, 75115

  • Study site

    Durham, North Carolina, 27707

  • Study site

    Escondido, California, 92025

  • Study site

    Fargo, North Dakota, 58102

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fort Lauderdale, Florida, 33319

  • Study site

    Gaithersburg, Maryland, 20877

  • Study site

    Garden Grove, California, 92845

  • Study site

    Glendale, California, 91206

  • Study site

    Hoffman Estates, Illinois, 60194

  • Study site

    Huntington Beach, California, 92648

  • Study site

    Irving, Texas, 75062

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Joliet, Illinois, 60077

  • Study site

    La Mesa, California, 91942

  • Study site

    Lake Charles, Louisiana, 70601

  • Study site

    Little Rock, Arkansas, 72201

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Memphis, Tennessee, 38105

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Murfressboro, Tennessee, 37129

  • Study site

    Naperville, Illinois, 60540

  • Study site

    Nashville, Tennessee, 37212

  • Study site

    National City, California, 91950

  • Study site

    New Britain, Connecticut, 06050

  • Study site

    New London, Connecticut, 06320

  • Study site

    New York, New York, 10035

  • Study site

    Norristown, Pennsylvania, 19401

  • Study site

    North Miami, Florida, 33161

  • Study site

    North Platte, Nebraska, 69101

  • Study site

    Oceanside, California, 92056

  • Study site

    Oklahoma City, Oklahoma, 73118

  • Study site

    Oklahoma City, Oklahoma, 73139

  • Study site

    Paramount, California, 90723

  • Study site

    Philadelphia, Pennsylvania, 19149

  • Study site

    Pittsburgh, Pennsylvania, 15108

  • Study site

    Rochester, New York, 14624

  • Study site

    Rosemead, California, 91770

  • Study site

    San Diego, California, 92108

  • Study site

    San Diego, California, 92123

  • Study site

    San Diego, California, 92126

  • Study site

    Santa Ana, California, 92705

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63118

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St. Petersburg, Florida, 33711

  • Study site

    Staten Island, New York, 10312

  • Study site

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
bifeprunox, olanzapine
Keywords
schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bifeprunox, olanzapineDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline on body weight at the final evaluation.

Secondary outcomes (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2006 (estimated)
  2. Study startJul 2006
  3. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00380224
Sponsor's protocol ID
3168A1-311
Status last verified
Dec 2007
First submitted
21 Sep 2006
Last updated
27 Dec 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bifeprunox, olanzapine in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 67 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline on body weight at the final evaluation.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00380224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2007.

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