Bipolar DisorderPhase 3NCT00060489
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
A Phase 3 study testing SEROQUEL (quetiapine fumarate) Tablets in people with Bipolar Disorder and Depression, Bipolar, run by AstraZeneca at 27 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Depression, Bipolar
- What is being tested?
- SEROQUEL (quetiapine fumarate) Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 27 sitesUnited States
- Study dates
- Sep 2002to Sep 2003
- 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
- Written Informed Consent;
- Bipolar disorder with most recent episode depressed;
- Outpatient status
Who cannot join
- Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Atlanta, Georgia
Study site
Austin, Texas
Study site
Bellevue, Washington
Study site
Beverly Hills, California
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Clementon, New Jersey
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Dayton, Ohio
Study site
Falls Church, Virginia
Study site
Jacksonville, Florida
Study site
Kirkland, Washington
Study site
La Mesa, California
Study site
Memphis, Tennessee
Study site
Moorestown, New Jersey
Study site
New York, New York
Study site
Oak Brook, Illinois
Study site
Orlando, Florida
Study site
Raleigh, North Carolina
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
Smyrna, Georgia
Study site
Staten Island, New York
Study site
West Palm Beach, Florida
Study site
Winter Park, Florida
About this study
The purpose of this study is to evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Being tested
- SEROQUEL (quetiapine fumarate) Tablets
- Keywords
- Bipolar Depression
- 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) TabletsDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2003 (estimated)
- Study startSep 2002
- Primary completionSep 2003
- Study completionSep 2003
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
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060489
- Sponsor's protocol ID
- 5077US/0049
- Status last verified
- Jan 2011
- First submitted
- 6 May 2003
- Last updated
- 26 Jan 2011
- 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 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
- ClinicalTrials.gov ID
- NCT00060489
- Acronym / sponsor ID
- 5077US/0049
- Conditions
- Bipolar Disorder, Depression, Bipolar
- Keywords
- Bipolar Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Sep 2003 (actual)
- Study completion
- Sep 2003 (actual)
- First posted
- 8 May 2003 (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 evaluate the efficacy and safety of quetiapine in the treatment of a major depressive episode in patients with bipolar disorder.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written Informed Consent;
- Bipolar disorder with most recent episode depressed;
- Outpatient status
Key exclusion criteria (2 listed)
- Patients with a current Axis I disorder other than bipolar disorder within 6 months of screening;
- Patients whose current episode of depression exceeds 12 months or is less than 4 weeks
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) Tablets | Drug | – |
Primary outcome
Not reported in the source record.
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 26 Jan 2011.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
27 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 SEROQUEL (quetiapine fumarate) Tablets in people with Bipolar Disorder and Depression, Bipolar, run by AstraZeneca at 27 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 2 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 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00060489, 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 26 Jan 2011.