Depression BipolarPhase 3NCT00245973
Study Evaluating Bifeprunox in Bipolar Depression
A Phase 3 study testing Bifeprunox in people with Depression Bipolar, run by Wyeth is now a wholly owned subsidiary of Pfizer at 40 sites in United States.
Trial summary
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Bipolar
- What is being tested?
- Bifeprunox
- How many people
- 380 participants
- Where
- 40 sitesUnited States
- Study dates
- Jun 2005to Oct 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
- Men and women 18 to 65 years of age, inclusive.
- Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.
Who cannot join
- This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Study site
Austin, Texas, 78756
Study site
Bellevue, Washington, 98004
Study site
Beverly Hills, California, 90210
Study site
Birmingham, Alabama, 35216
Study site
Boston, Massachusetts, 02114
Study site
Bradenton, Florida, 34208
Study site
Brown Deer, Wisconsin, 53223
Study site
Charleston, South Carolina, 29407
Study site
Cincinnati, Ohio, 45242
Study site
Clementon, New Jersey, 08021
Study site
Dallas, Texas, 75390
Study site
Dayton, Ohio, 45408
Study site
Farmington Hills, Connecticut, 06030
Study site
Farmington Hills, Michigan, 48336
Study site
Florence, Kentucky, 41042
Study site
Honolulu, Hawaii, 96826
Study site
Jacksonville, Florida, 32216
Study site
Lawrence, New York, 11559
Study site
Lyndhurst, Ohio, 44124
Study site
Moorestown, New Jersey, 08057
Study site
National City, California, 91950
Study site
New Orleans, Louisiana, 70115
Study site
New York, New York, 10021
Study site
New York, New York, 10024
Study site
Oklahoma City, Oklahoma, 73103
Study site
Orlando, Florida, 32806
Study site
Philadelphia, Pennsylvania, 19149
Study site
Portland, Oregon, 97210
Study site
Rockville, Maryland, 20852
Study site
Saint Charles, Missouri, 63301
Study site
Salt Lake City, Utah, 84107
Study site
Seattle, Washington, 98104
Study site
Smyrna, Georgia, 30080
Study site
Stanford, California, 94305
Study site
Staten Island, New York, 10305
Study site
Terre Haute, Indiana, 47802
Study site
The Bronx, New York, 10467
Study site
Tulsa, Oklahoma, 74135
Study site
West Palm Beach, Florida, 33407
Study site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder
The purpose of the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.
- Conditions
- Depression Bipolar
- Being tested
- Bifeprunox
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BifeprunoxDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary measurement scales will be used:
Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
Secondary outcomes (5)
Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startJun 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression BipolarStudies 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
- Double blind
- Enrolment
- 380 participants
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, MD, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245973
- Sponsor's protocol ID
- 3168A2-307
- Status last verified
- Dec 2007
- First submitted
- 27 Oct 2005
- Last updated
- 5 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Bifeprunox in the Treatment of Depression in Outpatients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00245973
- Acronym / sponsor ID
- 3168A2-307
- Conditions
- Depression Bipolar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Jun 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 28 Oct 2005 (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 the study is to investigate whether eight weeks of treatment with flexible doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women 18 to 65 years of age, inclusive.
- Diagnosis of Bipolar Disorder and must be experiencing a depressive episode.
Key exclusion criteria (1 listed)
- This is a follow on study to protocol 3168A2-304. Only subjects who have participated in the previous study are eligible.
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 | Drug | – |
Primary outcome
Secondary measurement scales will be used:
Hamilton Psychiatric Rating Scale for Depression (HAM-D17), at baseline, and weeks 1, 2, 3, 4, 6, and 8
5 secondary outcomes
Clinical Global Impressions Severity of Illness Score (CGI-S),at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Clinical Global Impressions Improvement Score (CG-I), at weeks 1, 2, 3, 4, 6, and 8
Young-Mania Rating Scale (Y-MRS), at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Positive and Negative Symptom Scale (PANSS) at at screening, baseline, and weeks 1, 2, 3, 4, 6, and 8
Covi Anxiety Scale at screening, baseline, and weeks 2, 4, 6, and 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2007.
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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, MD study director
Wyeth is now a wholly owned subsidiary of Pfizer
40 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 in people with Depression Bipolar, run by Wyeth is now a wholly owned subsidiary of Pfizer at 40 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 2 inclusion and 1 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 5 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 40 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?
Secondary measurement scales will be used:. The study lists 2 primary outcomes in all. 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 5 Dec 2007.