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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA017666 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their usual mood stabilizing medications relative to subjects treated with placebo plus usual mood stabilizing medications over a 16 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine | Experimental | Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks |
|
| Placebo | Placebo Comparator | Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine | Drug | Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Days Abstinent From Alcohol | Percentage of days in trial without consumption of alcoholic beverages per participant self-report; minimum = 0, maximum = 100; higher numbers indicate better outcome. Percent days abstinent was calculated as: (number of days abstinent per self-report / total number of days in trial)*100. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Heavy Drinking Days | Percentage of days in trial that were heavy drinking days (5 or more drinks/day for men, 4 or more drinks/day for women); minimum = 0, maximum = 100; lower numbers indicate better outcome. Percent heavy drinking days was calculated as: (number of days of heavy drinking per self-report / total number of days in trial)*100. | 12 weeks |
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Inclusion Criteria:
Age 18-65
Meet DSM-IV-TR criteria for current alcohol dependence with active alcohol use in the past 30 days
Meet DSM-IV-TR criteria for bipolar I or bipolar II disorder
Have average alcohol consumption of at least 35 drinks/week for men, 28 drinks/week for women in the last 4 weeks of active drinking prior to enrollment.
Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.
Must consent to random assignment and be willing to commit to medication treatment and follow-up assessments.
Currently under the care of a psychiatrist.
Must consent to sign a release of information allowing investigators to communicate with his/her psychiatrist to verify treatment history and facilitate care should treatment-emergent psychiatric symptoms develop during the trial.
Currently taking a therapeutic dosage of one or more mood stabilizing medications as defined by one or more of the following:
Stable psychiatric symptoms as defined by no changes to psychotropic drug regimen for 30 days
Must agree to identify collateral individuals for contact to facilitate follow-up appointments
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bryan K Tolliver, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Kathleen T Brady, M.D., Ph.D. | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lamotrigine | Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks |
| FG001 | Placebo | Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks Placebo: Placebo once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lamotrigine | Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks |
| BG001 |
| 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 | Percent Days Abstinent From Alcohol | Percentage of days in trial without consumption of alcoholic beverages per participant self-report; minimum = 0, maximum = 100; higher numbers indicate better outcome. Percent days abstinent was calculated as: (number of days abstinent per self-report / total number of days in trial)*100. | Analysis is of modified intention to treat (ITT) sample comprised of all randomized subjects who returned for at least one study visit after randomization. | Posted | Mean | Standard Deviation | Percentage of days abstinent | 12 weeks |
|
18 weeks (two-week baseline assessment phase, 12 week active medication phase, 4 week safety phase after medication discontinuation)
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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 | Lamotrigine | Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks Lamotrigine: Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Systematic Assessment | Active suicidal ideation with plan to overdose on medications |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
Relatively small sample size, suboptimal retention rate (58% of all randomized subjects)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan K. Tolliver, MD PhD | 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 |
| D011618 | Psychotic Disorders |
| D016739 | Behavior, Addictive |
| D060825 | Cognitive Dysfunction |
| D001008 | Anxiety Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo once daily for 12 weeks |
|
| Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT) | Serum levels of biomarkers of alcohol use: carbohydrate-deficient transferrin (CDT) at study endpoint in study completers | 12 weeks after randomization |
| Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT) | Serum levels of biomarkers of alcohol use: Gamma-glutamyltransferase (GGT) at study endpoint in study completers | 12 weeks after randomization |
| Montgomery-Asberg Depression Rating Scale (MADRS) Score | Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of ten (10) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes. | Baseline and 12 weeks |
| Young Mania Rating Scale (YMRS) Scores | Mania/hypomania symptoms at study endpoint as assessed by the Young Mania Rating Scale (YMRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of eleven (11) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes. | Baseline and 12 weeks |
| Neurocognitive Performance (California Verbal Learning Test) | Adjusted scale scores (T scores) on the California Verbal Learning Test (CVLT) of verbal working memory at study endpoint. CVLT Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (mean = 50; SD=10) with higher scores indicating better performance. | Study endpoint 12 weeks after randomization |
| Placebo |
Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks Placebo: Placebo once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks Placebo: Placebo once daily for 12 weeks |
|
|
| Secondary | Percent Heavy Drinking Days | Percentage of days in trial that were heavy drinking days (5 or more drinks/day for men, 4 or more drinks/day for women); minimum = 0, maximum = 100; lower numbers indicate better outcome. Percent heavy drinking days was calculated as: (number of days of heavy drinking per self-report / total number of days in trial)*100. | Analysis is of modified intention to treat (mITT) sample comprised of all randomized subjects who returned for at least one study visit after randomization (total mITT sample n=37). | Posted | Mean | Standard Deviation | Percentage of heavy drinking days | 12 weeks |
|
|
|
| Secondary | Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT) | Serum levels of biomarkers of alcohol use: carbohydrate-deficient transferrin (CDT) at study endpoint in study completers | The sample analyzed is limited to study completers (total n=25) due to this measure being obtained at study endpoint. | Posted | Mean | Standard Deviation | "percent CDT" | 12 weeks after randomization |
|
|
|
| Secondary | Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT) | Serum levels of biomarkers of alcohol use: Gamma-glutamyltransferase (GGT) at study endpoint in study completers | Sample in this analysis is limited to study completers only (total n=25) because this measure was obtained at study endpoint. | Posted | Mean | Standard Deviation | Units per liter (U/L) | 12 weeks after randomization |
|
|
|
| Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) Score | Scores on the Montgomery-Asberg Depression Rating Scale (MADRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of ten (10) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes. | All randomized subjects (total n=43) included in analysis at baseline. Study completers only (total n=25) included in analysis at study endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Young Mania Rating Scale (YMRS) Scores | Mania/hypomania symptoms at study endpoint as assessed by the Young Mania Rating Scale (YMRS) at baseline (all randomized subjects) and at study endpoint (study completers). Scores represent total summed score of eleven (11) subscale items; minimum = 0, maximum = 60, higher scores indicate worse outcomes. | Baseline YMRS scores include all randomized subjects (total n=43). Study endpoint YMRS scores include study completers only (total n=25). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | Neurocognitive Performance (California Verbal Learning Test) | Adjusted scale scores (T scores) on the California Verbal Learning Test (CVLT) of verbal working memory at study endpoint. CVLT Trials 1-5 Free Recall Total measures the sum of all word list items correctly recalled on learning trials 1 through 5. This raw score is converted to a T-score (mean = 50; SD=10) with higher scores indicating better performance. | Sample analyzed includes study completers only (total n=25) as this measure was obtained at study endpoint. | Posted | Mean | Standard Deviation | T scores | Study endpoint 12 weeks after randomization |
|
|
|
| 0 |
| 21 |
| 1 |
| 21 |
| 9 |
| 21 |
| EG001 | Placebo | Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks Placebo: Placebo once daily for 12 weeks | 0 | 22 | 1 | 22 | 9 | 22 |
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| Hospitalization (medical) after assault | Surgical and medical procedures | Systematic Assessment | Neurosurgical evacuation of epidural hematoma, intensive care required after serious assault |
|
| Erythema / skin discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Papular skin eruption | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Flu-like symptoms | General disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
|
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| D000068105 | Bipolar and Related 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 |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| MADRS score at study endpoint |
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|
| Endpoint YMRS scores |
|
|