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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Inactive ingredient matching the active medication in appearance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Heavy Drinking Days | 12 weeks | |
| Gamma-glutamyltransferase (GGT) | GGT is a liver enzyme measurement (IU/I) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Sherwood Brown, MD PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychoneuroendocrine Research Program | Dallas | Texas | 75235 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance. |
| FG001 | Quetiapine | 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. Quetiapine: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance. |
| BG001 | Quetiapine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure. | Posted | Least Squares Mean | Standard Error | drinks | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | This group will be given placebo matching quetiapine for the course of the 12 weeks in the study. Placebo: Inactive ingredient matching the active medication in appearance. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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Larger sample size possibly needed for between-group differences in outcome measures. Pill counts not an optimum measure of medication adherence.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E. Sherwood Brown, M.D., Ph.D., Professor | The University of Texas Southwestern Medical Center | 214-645-6950 | sherwood.brown@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000437 | Alcoholism |
| D000087122 | Mania |
| D003863 | Depression |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Quetiapine | Drug | 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. |
|
|
| Aspartate Aminotransferase (AST) |
AST is a liver enzyme measurement (IU/I) |
| 12 weeks |
| Alanine Aminotransferase (ALT) | ALT is a liver enzyme measurement (IU/I). | 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 | 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 | 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 | 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. | 12 weeks |
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.
Quetiapine: 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Married | Number | participants |
|
| Education | Mean | Standard Deviation | years |
|
| Mood states | Number | participants |
|
| History of treatment for drug/alcohol | Number | participants |
|
| % Days Alcohol Use In Past Week | Mean | Standard Deviation | days |
|
| % Days Heavy Alcohol Use In Past Week | Mean | Standard Deviation | Days |
|
| Drinks per day | Mean | Standard Deviation | drinks |
|
| Liver enzymes | Mean | Standard Deviation | IU/I |
|
| Concomitant medications | Number | participants |
|
| Concomitant medications | Number | participants |
|
| Concomitant medications | Number | participants |
|
| Concomitant medications | Number | participants |
|
| Mood and craving scales: Hamilton Rating Scale for Depression | Minimum: 0 Maximum: 50 Lower score associated with better outcome Normal= 7 or less | Mean | Standard Deviation | units on a scale |
|
| Mood and craving scales: Inventory of Depressive Symptomatology-Self-Report | Minimum= 0 Maximum= 84 Lower score associated with better outcome Normal= 7 or less | Mean | Standard Deviation | units on a scale |
|
| Mood and craving scales: Young Mania Rating Scale | Minimum: 0 Maximum: 60 Lower score associated with better outcome | Mean | Standard Deviation | units on a scale |
|
| Mood and craving scales: Penn Alcohol Craving Scale | Minimum: 0 Maximum: 30 Lower score associated with better outcome | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Percent of Heavy Drinking Days | Posted | Least Squares Mean | Standard Error | drinks | 12 weeks |
|
|
|
|
| Secondary | Gamma-glutamyltransferase (GGT) | GGT is a liver enzyme measurement (IU/I) | Missing data for 18 participants in placebo group and 11 participants in the quetiapine group. | Posted | Least Squares Mean | Standard Error | IU/I | 12 weeks |
|
|
|
|
| Secondary | Aspartate Aminotransferase (AST) | AST is a liver enzyme measurement (IU/I) | Missing data for 19 participants in placebo group and 11 participants in the quetiapine group. | Posted | Least Squares Mean | Standard Error | IU/I | 12 weeks |
|
|
|
|
| Secondary | Alanine Aminotransferase (ALT) | ALT is a liver enzyme measurement (IU/I). | Missing data for 17 participants in placebo group and 13 participants in the quetiapine group. | Posted | Least Squares Mean | Standard Error | IU/I | 12 weeks |
|
|
|
|
| Secondary | 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 | Missing data for 2 participants in placebo group and 3 participants in the quetiapine group. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| Secondary | 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 | Missing data for 4 participants in placebo group and 2 participants in the quetiapine group. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| Secondary | 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 | Missing data for 6 participants in placebo group and 1 participant in the quetiapine group. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| Secondary | 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. | Missing data for 1 participants in placebo group and 5 participants in the quetiapine group. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
|
| 3 |
| 45 |
| 0 |
| 45 |
| EG001 | Quetiapine | 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. Quetiapine: 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. | 5 | 45 | 0 | 45 |
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Victim of Sexual Assault | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arrest for Public Intoxication | Psychiatric disorders | Non-systematic Assessment |
|
| Panic Attack | Psychiatric disorders | Non-systematic Assessment |
|
| Asthma Exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |