SchizophreniaPhase 3NCT00366704
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint
A Phase 3 study testing bifeprunox and risperidone in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 66 sites in United States.
Trial summary
The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia. 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 and risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 66 sitesUnited States
- Study dates
- Nov 2006to Mar 2008
- 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 risperidone.
- Primary diagnosis of schizophrenia.
- Total Positive and Negative Symptoms Scale (PANSS) score < or = 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
66 sites in 1 country.
66 sites in 1 country
United States66 sites
Study site
Anaheim, California, 92802
Study site
Anaheim, California, 92804
Study site
Anaheim, California, 92805
Study site
Atlanta, Georgia, 30307
Study site
Atlanta, Georgia, 30308
Study site
Augusta, Georgia, 30912
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Austin, Texas, 78756
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Beachwood, Ohio, 44122
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Boynton Beach, California, 33426
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Butner, North Carolina, 27509
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Cherry Hill, New Jersey, 08002
Study site
Chicago, Illinois, 60631
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Clementon, New Jersey, 08021
Study site
Cleveland, Ohio, 44109
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Coevr d'Alene, Idaho, 83814
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Cordova, Tennessee, 38018
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Costa Mesa, California, 92363
Study site
Costa Mesa, California, 92627
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DeSoto, Texas, 75115
Study site
East Stroudsberg, Pennsylvania, 18301
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Escondido, California, 92025
Study site
Flowood, Mississippi, 39232
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Fort Lauderdale, Florida, 33319
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Gaithersburg, Maryland, 20877
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Garden Grove, California, 92845
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Glendale, California, 91206
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Hoffman Estates, Illinois, 60194
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Huntington Beach, California, 92648
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Irving, Texas, 75062
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Jacksonville, Florida, 32256
Study site
Jenkintown, Pennsylvania, 19046
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Joliet, Illinois, 60077
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La Mesa, California, 91942
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Lake Charles, Louisiana, 70601
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Little Rock, Arkansas, 72201
Study site
Little Rock, Arkansas, 72211
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38105
Study site
Memphis, Tennessee, 38157
Study site
Morehead City, North Carolina, 28557
Study site
Naperville, Illinois, 60540
Study site
National City, California, 91950
Study site
New London, Connecticut, 06320
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, 73139
Study site
Paramount, California, 90723
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Philadelphia, Pennsylvania, 19149
Study site
Pittsburgh, Pennsylvania, 15108
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Pittsfield, Massachusetts, 01201
Study site
Rochester, New York, 14624
Study site
Rosemead, California, 91770
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92108
Study site
San Diego, California, 92123
Study site
San Diego, California, 92126
Study site
Santa Ana, California, 92701
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
About this 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.
The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- bifeprunox, risperidone
- 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.
bifeprunoxDrug
.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)
risperidoneDrug
4mg, QD, 8 week treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: bifeprunox |
| B | Active comparator | Not described Receives: Drug: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be the change from baseline on body weight at the final evaluation.
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00366704
- Sponsor's protocol ID
- 3168A1-313
- Other IDs
- B3101009
- Status last verified
- Apr 2008
- First submitted
- 17 Aug 2006
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00366704
- Acronym / sponsor ID
- 3168A1-313
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 21 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: bifeprunox |
| B | Active comparator | Drug: risperidone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bifeprunox.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8) | Drug | A |
| risperidone4mg, QD, 8 week treatment | Drug | B |
Primary outcome
The primary analysis will be the change from baseline on body weight at the final evaluation.
Time frame: 8 weeks
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
66 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bifeprunox and risperidone in people with Schizophrenia, run by Wyeth is now a wholly owned subsidiary of Pfizer at 66 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: stopped early, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 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 was stopped early. Results are not available in the source record.
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?
The primary analysis will be the change from baseline on body weight at the final evaluation. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2013.