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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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To conduct a double-blind, randomized, placebo-controlled outpatient clinical trial of acamprosate in individuals with alcohol dependence and bipolar disorder who are also receiving mood stabilizing medication. The study will assess the safety and efficacy of acamprosate in alcohol-dependent bipolar patients as measured by its effects on alcohol use and mood symptoms relative to placebo.
The primary hypothesis to be tested is whether individuals with comorbid bipolar disorder and alcohol dependence who receive acamprosate plus mood stabilizer will have greater improvement in alcohol-related outcomes than those who receive mood stabilizer alone. A secondary hypothesis that will be explored is that alcohol-dependent bipolar individuals treated with acamprosate will have greater mood stability as compared to those treated with mood stabilizers alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acamprosate | Experimental | 666 mg p.o. TID |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate | Drug | 666 mg po TID |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Drink (Days) | Number of days after randomization until consumption of first alcoholic beverage per self-report. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Days Abstinent | Percentage of days in trial with no alcohol consumption | 8 weeks |
| Percent Heavy Drinking Days | Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan K Tolliver, M.D., Ph.D. | Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina | Principal Investigator |
| Kathleen T Brady, M.D., Ph.D. | Division of Clinical Neuroscience, Department of Psychiatry, Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Psychiatry, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
Two week lead-in (Screening, Baseline)
Recruitment by clinical referral
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| ID | Title | Description |
|---|---|---|
| FG000 | Acamprosate | 666 mg p.o. TID |
| FG001 | Placebo | Matching placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acamprosate | 666 mg p.o. TID |
| BG001 | Placebo | Matching placebo |
| BG002 |
| 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 | Time to First Drink (Days) | Number of days after randomization until consumption of first alcoholic beverage per self-report. | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | 95% Confidence Interval | Days | 8 weeks |
|
8 weeks
Known adverse events and or serious adverse events are reported for a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). Adverse event data (all-cause mortality, serious adverse events, all other adverse events) could not be obtained in randomized participants lost to follow-up (n=3).
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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 | Acamprosate | Participants assigned to acamprosate | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Limited sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan K. Tolliver, M.D., Ph.D. (Principal Investigator) | Medical University of South Carolina | (843) 792-4869 | tollive@musc.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D001714 | Bipolar Disorder |
| D003863 | Depression |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077443 | Acamprosate |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Drug |
2 tabs po TID |
|
| 8 weeks |
| Percent Carbohydrate-deficient Transferrin | Measured level of validated serum alcohol biomarker | 8 weeks |
| Gamma-glutamyltransferase | Measured levels of validated serum alcohol biomarker | 8 weeks |
| Obsessive Compulsive Drinking Scale Score | Higher scores indicate worse outcome; minimum score = 0, maximum score = 40 | 8 weeks |
| Montgomery Asberg Depression Rating Scale Score | MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60. | 8 weeks |
| Young Mania Rating Scale Score | YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60. | 8 weeks |
| Clinical Global Impression Scale Score | Higher values indicate worse outcomes; minimum value = 1, maximum value = 7 | 8 weeks |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percent Days Abstinent | Percentage of days in trial with no alcohol consumption | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | percentage of days in trial | 8 weeks |
|
|
|
| Secondary | Percent Heavy Drinking Days | Percentage of drinking days that are heavy drinking days (5 or more standard drinks/day for males, 4 or more standard drinks/day for females) | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | percentage of days drinking | 8 weeks |
|
|
|
| Secondary | Percent Carbohydrate-deficient Transferrin | Measured level of validated serum alcohol biomarker | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | "percent CDT" | 8 weeks |
|
|
|
| Secondary | Gamma-glutamyltransferase | Measured levels of validated serum alcohol biomarker | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | Gamma-glutamyltransferase U/L | 8 weeks |
|
|
|
| Secondary | Obsessive Compulsive Drinking Scale Score | Higher scores indicate worse outcome; minimum score = 0, maximum score = 40 | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Montgomery Asberg Depression Rating Scale Score | MADRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60. | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Young Mania Rating Scale Score | YMRS scores at study endpoint. Higher scores indicate a worse outcome. Minimum score = 0, maximum score = 60. | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| Secondary | Clinical Global Impression Scale Score | Higher values indicate worse outcomes; minimum value = 1, maximum value = 7 | Sample analyzed is a modified intention to treat (mITT) sample of all randomized subjects who returned for at least one visit post-randomization (total mITT n=30). | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
|
|
|
| 14 |
| 3 |
| 14 |
| 6 |
| 14 |
| EG001 | Placebo | Participants assigned to placebo | 0 | 16 | 3 | 16 | 8 | 16 |
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Anaphylactoid skin reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Diffuse aches | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |