A Phase 4 interventional study of Placebo and Quetiapine in Bipolar Disorder and Alcohol Dependence, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
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.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's enrollment of 90 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Drug: Placebo
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.
Drug: Quetiapine
Inactive ingredient matching the active medication in appearance.
Also known as: Sugar-pill
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.
Also known as: Seroquel, Xeroquel, Ketipinor
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Time frame: 12 weeks
Percent of Heavy Drinking Days
Time frame: 12 weeks
Gamma-glutamyltransferase (GGT)
GGT is a liver enzyme measurement (IU/I)
Time frame: 12 weeks
Aspartate Aminotransferase (AST)
AST is a liver enzyme measurement (IU/I)
Time frame: 12 weeks
Alanine Aminotransferase (ALT)
ALT is a liver enzyme measurement (IU/I).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 12 weeks
| Milestone | Placebo | Quetiapine |
|---|---|---|
| Started | 45 | 45 |
| Completed | 44 | 44 |
| Not completed | 1 | 1 |
| drinks | Placebo | Quetiapine |
|---|---|---|
| The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure. | 10.6 ± 2.465 | 8.09 ± 2.465 |
| drinks | Placebo | Quetiapine |
|---|---|---|
| Percent of Heavy Drinking Days | 28.8 ± 3.66 | 20.8 ± 3.66 |
GGT is a liver enzyme measurement (IU/I)
| IU/I | Placebo | Quetiapine |
|---|---|---|
| Gamma-glutamyltransferase (GGT) | 66.6 ± 8.34 | 66.0 ± 7.38 |
AST is a liver enzyme measurement (IU/I)
| IU/I | Placebo | Quetiapine |
|---|---|---|
| Aspartate Aminotransferase (AST) | 29.7 ± 2.92 | 31.1 ± 2.54 |
ALT is a liver enzyme measurement (IU/I).
| IU/I | Placebo | Quetiapine |
|---|---|---|
| Alanine Aminotransferase (ALT) | 25.1 ± 2.61 | 30.4 ± 2.43 |
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
| units on a scale | Placebo | Quetiapine |
|---|---|---|
| Hamilton Rating Scale for Depression (HRSD) | 10.9 ± 1.10 | 10.3 ± 1.12 |
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
| units on a scale | Placebo | Quetiapine |
|---|---|---|
| Inventory of Depressive Symptomatology-Self Report (IDS-SR) | 19.0 ± 1.79 | 21.9 ± 1.75 |
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
| units on a scale | Placebo | Quetiapine |
|---|---|---|
| Young Mania Rating Scale (YMRS) | 8.70 ± 1.09 | 8.48 ± 1.02 |
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.
| units on a scale | Placebo | Quetiapine |
|---|---|---|
| Penn Alcohol Craving Scale (PACS) | 14.1 ± 1.03 | 12.3 ± 1.09 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 3/45 (6.7%) | 0/45 (0%) |
| Quetiapine | — | 5/45 (11.1%) | 0/45 (0%) |
| Event | Placebo | Quetiapine |
|---|---|---|
| FallInjury, poisoning and procedural complications | 2/45 | 0/45 |
| Myocardial InfarctionCardiac disorders | 0/45 | 1/45 |
| Victim of Sexual AssaultInjury, poisoning and procedural complications | 0/45 | 1/45 |
| Arrest for Public IntoxicationPsychiatric disorders | 1/45 | 1/45 |
| Panic AttackPsychiatric disorders | 0/45 | 1/45 |
| Asthma ExacerbationRespiratory, thoracic and mediastinal disorders | 0/45 | 1/45 |
| Age, Continuous(years) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Mean | 39.7 ± 10.1 | 43.3 ± 8.2 | 41.5 ± 9.2 |
| Sex: Female, Male(Participants) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Female | 19 | 17 | 36 |
| Male | 25 | 27 | 52 |
| Race/Ethnicity, Customized(participants) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Caucasian | 21 | 21 | 42 |
| African American | 12 | 13 | 25 |
| Hispanic | 10 | 7 | 17 |
| Other | 1 | 2 | 3 |
| Missing | 0 | 1 | 1 |
| Married(participants) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Married | 8 | 10 | 18 |
| Not Married | 36 | 34 | 70 |
| Education(years) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Mean | 13.3 ± 2.4 | 13.6 ± 2.5 | 13.5 ± 2.5 |
| Mood states(participants) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Depressed | 40 | 38 | 78 |
| Mixed (both depression and mania at same time) | 4 | 6 | 10 |
| History of treatment for drug/alcohol(participants) | Placebo | Quetiapine | Total |
|---|---|---|---|
| History | 25 | 30 | 55 |
| No History | 19 | 14 | 33 |
| % Days Alcohol Use In Past Week(days) | Placebo | Quetiapine | Total |
|---|---|---|---|
| Mean | 74.6 ± 26.1 | 74.2 ± 27.3 | 74.4 ± 26.7 |
11 further baseline measures are reported on the registry.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Quetiapine
University of Texas Southwestern Medical Center →