Bipolar DisorderPhase 3NCT00081380
Efficacy and Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
A Phase 3 study testing Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer) and divalproex (mood stabilizer) in people with Bipolar Disorder, run by AstraZeneca at 94 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer) and divalproex (mood stabilizer)
- How many people
- 710 participants
- Where
- 94 sitesin 2 countries
- Study dates
- Mar 2004to Sep 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open-Label
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
- Able to understand and comply with the requirements of the study.
Who cannot join
- Open-Label
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
- Previously randomized into this study or D1447C00126
Trial locations and contacts
94 sites in 2 countries.
94 sites in 2 countries
United States81 sites
Research Site
Albuquerque, New Mexico
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Anaheim, California
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Atlanta, Georgia
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Austin, Texas
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Baltimore, Maryland
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Beachwood, Ohio
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Bellevue, Washington
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Birmingham, Alabama
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Brooklyn, New York
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Butner, North Carolina
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Cerritos, California
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Charleston, South Carolina
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Charlottesville, Virginia
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Chicago, Illinois
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Chula Vista, California
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Cincinnati, Ohio
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Clementon, New Jersey
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Culver City, California
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Dallas, Texas
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Dayton, Ohio
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Decatur, Georgia
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DeSoto, Texas
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Emmaus, Pennsylvania
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Eugene, Oregon
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Evansville, Indiana
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Falls Church, Virginia
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Farmington, Connecticut
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Florence, Kentucky
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Garden Grove, California
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Greenwood, Indiana
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Hoffman Estates, Illinois
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Honolulu, Hawaii
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Houston, Texas
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Indianapolis, Indiana
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Irving, Texas
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Jacksonville, Florida
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Joliet, Illinois
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Kirkland, Washington
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La Mesa, California
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Lake Charles, Louisiana
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Little Rock, Arkansas
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Marietta, Georgia
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Medina, Ohio
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Memphis, Tennessee
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Miami, Florida
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Moon Township, Pennsylvania
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Moorestown, New Jersey
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Morgantown, West Virginia
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New Baltimore, Michigan
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New Britain, Connecticut
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New Orleans, Louisiana
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New York, New York
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Oceanside, California
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Oklahoma City, Oklahoma
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Orange, California
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Orlando, Florida
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Philadelphia, Pennsylvania
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Pico Rivera, California
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Pittsfield, Massachusetts
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Portland, Oregon
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Raleigh, North Carolina
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Richmond, Virginia
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Riverside, California
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Rockville, Maryland
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Rosemead, California
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San Antonio, Texas
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San Diego, California
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San Francisco, California
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Santa Ana, California
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Scottsdale, Arizona
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Shreveport, Louisiana
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Smyrna, Georgia
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St Louis, Missouri
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The Bronx, New York
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Tulsa, Oklahoma
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Virginia Beach, Virginia
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West Caldwell, New Jersey
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West Palm Beach, Florida
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Wichita, Kansas
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Wichita Falls, Texas
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Winter Park, Florida
Canada13 sites
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Edmonton, Alberta
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Halifax, Nova Scotia
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Hamilton, Ontario
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Kingston, Ontario
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Markham, Ontario
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Mississauga, Ontario
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Montreal, Quebec
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Oshawa, Ontario
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Québec, Quebec
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
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Winnipeg, Manitoba
About this study
Official title: Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
- Conditions
- Bipolar Disorder
- Being tested
- Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer), divalproex (mood stabilizer)
- Keywords
- Bipolar I Disorder, Manic Depressive Disorder, Manic Depression, Mixed
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seroquel®, quetiapine fumarate (atypical antipsychotic)Drug
lithium (mood stabilizer)Drug
divalproex (mood stabilizer)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Secondary outcomes (1)
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2004 (estimated)
- Study startMar 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 710 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Seroquel Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081380
- Sponsor's protocol ID
- D1447C00127
- Status last verified
- Dec 2008
- First submitted
- 9 Apr 2004
- Last updated
- 22 Dec 2008
- Results posted
- No
Publications
Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
PubMed 23761037
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
- ClinicalTrials.gov ID
- NCT00081380
- Acronym / sponsor ID
- D1447C00127
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder, Manic Depressive Disorder, Manic Depression, Mixed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 710 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 19 Apr 2004 (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 whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Open-Label
- A diagnosis of Bipolar I Disorder, Most recent episode Manic (296.4x), or Bipolar I Disorder, Most Recent Episode Depressed (296.5x), or Bipolar I Disorder, Most recent Episode Mixed (296.6x), with or without psychotic features, as defined by Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV)
- At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
- Able to understand and comply with the requirements of the study.
Key exclusion criteria (4 listed)
- Open-Label
- Diagnosis of an anxiety disorder as defined by DSM-IV, which was treated with medication within the past year.
- Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
- Previously randomized into this study or D1447C00126
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 |
|---|---|---|
| Seroquel®, quetiapine fumarate (atypical antipsychotic) | Drug | – |
| lithium (mood stabilizer) | Drug | – |
| divalproex (mood stabilizer) | Drug | – |
Primary outcome
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
1 secondary outcome
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event.
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 22 Dec 2008.
- Derived from this study: PubMed 23761037Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12.
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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.
AstraZeneca Seroquel Medical Science Director, MD study director
AstraZeneca
94 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer) and divalproex (mood stabilizer) in people with Bipolar Disorder, run by AstraZeneca at 94 sites in 2 countries.
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 4 inclusion and 4 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 22 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Canada. 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?
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.. 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 NCT00081380, which also lists 1 linked publication.
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 22 Dec 2008.