Bipolar I DisorderPhase 3NCT00114686
Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Alcohol Dependency in Patients With Bipolar Disorder
A Phase 3 study testing Quetiapine fumarate, lithium and divalproex in people with Bipolar I Disorder and Alcohol Dependence, run by AstraZeneca at 38 sites in United States.
Trial summary
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Bipolar I Disorder, Alcohol Dependence
- What is being tested?
- Quetiapine fumarate, lithium and divalproex
- How many people
- 350 participants
- Where
- 38 sitesUnited States
- Study dates
- Jan 2006to Apr 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for Bipolar I Disorder with Alcohol dependence
- Outpatient Status
- Recent history of heavy drinking
Who cannot join
- Unstable medical illness
- Recent antipsychotic use
- Poorly controlled Diabetes Mellitus or Diabetes related illness
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Research Site
Albuquerque, New Mexico
Research Site
Austin, Texas
Research Site
Bellevue, Washington
Research Site
Boston, Massachusetts
Research Site
Cerritos, California
Research Site
Chapel Hill, North Carolina
Research Site
Cincinnati, Ohio
Research Site
Cleveland, Ohio
Research Site
Columbia, South Carolina
Research Site
Dallas, Texas
Research Site
Dayton, Ohio
Research Site
Eagle, Idaho
Research Site
Glen Burnie, Maryland
Research Site
Houston, Texas
Research Site
Jacksonville, Florida
Research Site
Kirkland, Washington
Research Site
Maitland, Florida
Research Site
Media, Pennsylvania
Research Site
Memphis, Tennessee
Research Site
Milwaukee, Wisconsin
Research Site
Moorestown, New Jersey
Research Site
Nashville, Tennessee
Research Site
New Haven, Connecticut
Research Site
New York, New York
Research Site
Orlando, Florida
Research Site
Philadelphia, Pennsylvania
Research Site
Pittsburgh, Pennsylvania
Research Site
Portland, Oregon
Research Site
Research Triangle Park, North Carolina
Research Site
Richmond, Virginia
Research Site
San Antonio, Texas
Research Site
San Diego, California
Research Site
Seattle, Washington
Research Site
Shreveport, Louisiana
Research Site
St Louis, Missouri
Research Site
Staten Island, New York
Research Site
The Bronx, New York
Research Site
Wichita Falls, Texas
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder
The purpose of this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence
- Conditions
- Bipolar I Disorder, Alcohol Dependence
- Being tested
- Quetiapine fumarate, lithium, divalproex
- Keywords
- Bipolar I Disorder, Alcohol Dependency
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
lithiumDrug
divalproexDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
Secondary outcomes (2)
Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2005 (estimated)
- Study startJan 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 350 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
- NCT00114686
- Sponsor's protocol ID
- D144AL00002
- Status last verified
- Jan 2013
- First submitted
- 16 Jun 2005
- Last updated
- 4 Jan 2013
- Results posted
- No
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 Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients With Bipolar I Disorder
- ClinicalTrials.gov ID
- NCT00114686
- Acronym / sponsor ID
- D144AL00002
- Conditions
- Bipolar I Disorder, Alcohol Dependence
- Keywords
- Bipolar I Disorder, Alcohol Dependency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 17 Jun 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 this study is to determine whether treatment with Quetiapine Fumarate (SEROQUEL) in conjunction with mood stabilizers (Lithium or Divalproex) for 12 weeks helps patients who have Bipolar I Disorder with Alcohol Dependence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets criteria for Bipolar I Disorder with Alcohol dependence
- Outpatient Status
- Recent history of heavy drinking
Key exclusion criteria (3 listed)
- Unstable medical illness
- Recent antipsychotic use
- Poorly controlled Diabetes Mellitus or Diabetes related illness
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 | – |
| lithium | Drug | – |
| divalproex | Drug | – |
Primary outcome
Change in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale
2 secondary outcomes
Change in the mean number of standardized drinks per day from Baseline to Week 12 & to monthly intervals, as derived from the TLFB scale
Change in manic symptoms as assessed by the change from Baseline to each visit in the Young Mania Rating Scale (YMRS) total score
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.
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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
38 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, lithium and divalproex in people with Bipolar I Disorder and Alcohol Dependence, run by AstraZeneca at 38 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: 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 38 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 in the proportion of heavy drinking days from Baseline to Week 12, as derived from the Timeline Followback (TLFB) scale. 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 4 Jan 2013.