Bipolar DisorderPhase 4NCT00457197
Quetiapine for Bipolar Disorder and Alcohol Dependence
A Phase 4 study testing Quetiapine in people with Bipolar Disorder and Alcohol Dependence, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Alcohol Dependence
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) and confirmed by interview with PI or co-I.
- Current diagnosis of alcohol dependence.
- Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.
- Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid, oxcarbazepine, or lamotrigine at a stable dose for > 14 days.
- Men and women age 18-65 years old.
- English or Spanish speaking.
Who cannot join
- Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
- Baseline Young Mania Rating Scale (YMRS) score > 35 or Hamilton Depression Rating Scale (HRSD) 17 score > 35.
- Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).
- Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical Institute Withdrawal Assessment (CIWA-AR) score of > 8.
- History of hepatic cirrhosis or baseline AST or ALT > 3X upper limit of normal or other clinically significant findings on physical or laboratory examination.
- Mental retardation or other severe cognitive impairment.
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- Prison or jail inmates.
- Pregnant or nursing women or women of childbearing age who will not use oral contraceptives, abstinence, or other acceptable methods of birth control during the study.
- Antipsychotic therapy within 14 days prior to randomization.
- Current carbamazepine or benzodiazepine therapy.
- Current treatment with medications shown to reduce alcohol consumption (naltrexone, acamprosate, disulfiram, or topiramate) in large randomized, controlled trials.
- Initiation of antidepressants or mood stabilizers or psychotherapy within past 2 weeks.
- High risk for suicide, defined as any suicide attempts in the past 3 months or current suicidal ideation with plan and intent.
- Intensive outpatient treatment for substance abuse (AA, NA meetings, or other 12-step programs or weekly psychotherapy that started at least 14 days prior to randomization will be allowed).
- Current treatment with ketoconazole, itraconazole, erythromycin, or nefazodone.
- Severe or life-threatening medical condition (e.g., congestive heart failure, terminal cancer) or laboratory or physical examination findings consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).
- Diabetes mellitus by history or suspected from baseline blood sugar.
- History of cataracts or suspected cataracts on ophthalmic exam
- History of seizure disorder of any etiology; if a subject develops a seizure episode, s/he will be discontinued from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psychoneuroendocrine Research Program
Dallas, Texas, 75235
About this study
The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.
Read the detailed description
The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.
- Conditions
- Bipolar Disorder, Alcohol Dependence
- Being tested
- Placebo, Quetiapine
- Keywords
- bipolar disorder, alcohol dependence, mania, manic disorder, depression
- Medical subject headings
- Bipolar Disorder, Alcoholism, Mania, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sugar-pill
Inactive ingredient matching the active medication in appearance.
QuetiapineDrug
Also called Seroquel, Xeroquel, Ketipinor
Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Receives: Drug: Placebo |
| Quetiapine | Active comparator | This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Measured: 12 weeks
Secondary outcomes (8)
Percent of Heavy Drinking Days
Measured: 12 weeks
Gamma-glutamyltransferase (GGT)
GGT is a liver enzyme measurement (IU/I)
Measured: 12 weeks
Aspartate Aminotransferase (AST)
AST is a liver enzyme measurement (IU/I)
Measured: 12 weeks
Alanine Aminotransferase (ALT)
ALT is a liver enzyme measurement (IU/I).
Measured: 12 weeks
Hamilton Rating Scale for Depression (HRSD)
The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).
Scale:
Minimum: 0 Maximum: 50 Lower score associated with better outcome
Measured: 12 weeks
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.
Score:
Minimum: 0 Maximum: 84 Lower score associated with better outcome
Measured: 12 weeks
Young Mania Rating Scale (YMRS)
This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).
Score:
Minimum: 0 Maximum: 60 Lower score associated with better outcome
Measured: 12 weeks
Penn Alcohol Craving Scale (PACS)
The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking
Score:
Minimum: 0 Maximum: 30 Lower score associated with better outcome.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E. Sherwood Brown, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457197
- Sponsor's protocol ID
- STU 072010-090
- Status last verified
- Jul 2025
- First submitted
- 4 Apr 2007
- Last updated
- 25 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quetiapine for Bipolar Disorder and Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00457197
- Acronym / sponsor ID
- STU 072010-090
- Conditions
- Bipolar Disorder, Alcohol Dependence
- Keywords
- bipolar disorder, alcohol dependence, mania, manic disorder, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Posted 28 Jan 2016
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 find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.
Detailed description
The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboThis group will be given placebo matching quetiapine for the course of the 12 weeks in the study. |
| Quetiapine | Active comparator | Drug: QuetiapineThis group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) and confirmed by interview with PI or co-I.
- Current diagnosis of alcohol dependence.
- Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.
- Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid, oxcarbazepine, or lamotrigine at a stable dose for > 14 days.
- Men and women age 18-65 years old.
Key exclusion criteria (19 listed)
- Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
- Baseline Young Mania Rating Scale (YMRS) score > 35 or Hamilton Depression Rating Scale (HRSD) 17 score > 35.
- Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).
- Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical Institute Withdrawal Assessment (CIWA-AR) score of > 8.
- History of hepatic cirrhosis or baseline AST or ALT > 3X upper limit of normal or other clinically significant findings on physical or laboratory examination.
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 |
|---|---|---|
| PlaceboAlso: Sugar-pillInactive ingredient matching the active medication in appearance. | Drug | Placebo |
| QuetiapineAlso: Seroquel, Xeroquel, KetipinorQuetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder. | Drug | Quetiapine |
Primary outcome
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Time frame: 12 weeks
8 secondary outcomes
Percent of Heavy Drinking Days
Time frame: 12 weeks
Gamma-glutamyltransferase (GGT)
Time frame: 12 weeks
Aspartate Aminotransferase (AST)
Time frame: 12 weeks
Alanine Aminotransferase (ALT)
Time frame: 12 weeks
Hamilton Rating Scale for Depression (HRSD)
Time frame: 12 weeks
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Time frame: 12 weeks
Young Mania Rating Scale (YMRS)
Time frame: 12 weeks
Penn Alcohol Craving Scale (PACS)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
E. Sherwood Brown, MD PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine in people with Bipolar Disorder and Alcohol Dependence, run by University of Texas Southwestern Medical Center at 1 site 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 6 inclusion and 19 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 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure. (time frame: 12 weeks). 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 25 Jul 2025.