Bipolar DisorderPhase 3NCT00083954
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression
A Phase 3 study testing Quetiapine Fumarate in people with Bipolar Disorder, run by AstraZeneca at 36 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Quetiapine Fumarate
- How many people
- 530 participants
- Where
- 36 sitesUnited States
- Study dates
- Jun 2004to Aug 2005
- 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
- Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status
Who cannot join
- More than 8 mood episodes in the past year from screen (visit 1);
- A current Axis I disorder other than bipolar disorder within 6 months of screening;
- patients with clinically significant abnormal laboratory findings in the investigator's judgment
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Research Site
Albuquerque, New Mexico
Research Site
Austin, Texas
Research Site
Baltimore, Maryland
Research Site
Bellevue, Washington
Research Site
Birmingham, Alabama
Research Site
Boise, Idaho
Research Site
Brooklyn, New York
Research Site
Cerritos, California
Research Site
Charleston, South Carolina
Research Site
Cincinnati, Ohio
Research Site
Clementon, New Jersey
Research Site
Dayton, Ohio
Research Site
Garden Grove, California
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Kirkland, Washington
Research Site
Maitland, Florida
Research Site
Memphis, Tennessee
Research Site
Moorestown, New Jersey
Research Site
New York, New York
Research Site
Oak Brook, Illinois
Research Site
Oklahoma City, Oklahoma
Research Site
Orlando, Florida
Research Site
Overbrook Terrace, Illinois
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Portland, Oregon
Research Site
Raleigh, North Carolina
Research Site
Salt Lake City, Utah
Research Site
San Diego, California
Research Site
Scottsdale, Arizona
Research Site
Seattle, Washington
Research Site
Shreveport, Louisiana
Research Site
Staten Island, New York
Research Site
Torrance, California
Research Site
Winter Park, Florida
About this study
Official title: A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression
The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
- Conditions
- Bipolar Disorder
- Being tested
- Quetiapine Fumarate
- Keywords
- Bipolar I Disorder
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine FumarateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
Secondary outcomes (1)
Evaluate the incidence of treatment-emergent mania compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2004 (estimated)
- Study startJun 2004
- Study completionAug 2005
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 530 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
- NCT00083954
- Sponsor's protocol ID
- D1447C00135
- Status last verified
- Jan 2013
- First submitted
- 3 Jun 2004
- Last updated
- 4 Jan 2013
- Results posted
- No
Publications
Lydiard RB, Culpepper L, Schioler H, Gustafsson U, Paulsson B. Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659.
PubMed 19956459
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression
- ClinicalTrials.gov ID
- NCT00083954
- Acronym / sponsor ID
- D1447C00135
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar I Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 7 Jun 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 the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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 (1 listed)
- Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status
Key exclusion criteria (3 listed)
- More than 8 mood episodes in the past year from screen (visit 1);
- A current Axis I disorder other than bipolar disorder within 6 months of screening;
- patients with clinically significant abnormal laboratory findings in the investigator's judgment
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 |
|---|---|---|
| Quetiapine Fumarate | Drug | – |
Primary outcome
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score
1 secondary outcome
Evaluate the incidence of treatment-emergent mania compared to placebo
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 4 Jan 2013.
- Derived from this study: PubMed 19956459Lydiard RB, Culpepper L, Schioler H, Gustafsson U, Paulsson B. Quetiapine monotherapy as treatment for anxiety symptoms in patients with bipolar depression: a pooled analysis of results from 2 double-blind, randomized, placebo-controlled studies. Prim Care Companion J Clin Psychiatry. 2009;11(5):215-25. doi: 10.4088/PCC.08m00659.
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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
36 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 Quetiapine Fumarate in people with Bipolar Disorder, run by AstraZeneca at 36 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 1 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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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 to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score. 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 NCT00083954, 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 4 Jan 2013.