A Phase 4 interventional study of Lamotrigine and Placebo in Alcohol Dependence, Bipolar Disorder and Depression, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 43 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) 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.
Currently taking a therapeutic dosage of one or more mood stabilizing medications as defined by one or more of the following:
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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
Drug: Lamotrigine
Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks
Drug: Placebo
Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks
Placebo once daily for 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Study endpoint 12 weeks after randomization
| Milestone | Lamotrigine | Placebo |
|---|---|---|
| Started | 21 | 22 |
| Completed | 14 | 11 |
| Not completed | 7 | 11 |
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.
| Percentage of days abstinent | Lamotrigine | Placebo |
|---|---|---|
| Percent Days Abstinent From Alcohol | 78.7 ± 30.0 | 80.1 ± 28.4 |
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.
| Percentage of heavy drinking days | Lamotrigine | Placebo |
|---|---|---|
| Percent Heavy Drinking Days | 8.1 ± 12.8 | 11.6 ± 21.1 |
Serum levels of biomarkers of alcohol use: carbohydrate-deficient transferrin (CDT) at study endpoint in study completers
| "percent CDT" | Lamotrigine | Placebo |
|---|---|---|
| Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT) | 1.41 ± .48 | 1.26 ± .18 |
Serum levels of biomarkers of alcohol use: Gamma-glutamyltransferase (GGT) at study endpoint in study completers
| Units per liter (U/L) | Lamotrigine | Placebo |
|---|---|---|
| Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT) | 62.5 ± 139.4 | 22.9 ± 10.7 |
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.
| units on a scale | Lamotrigine | Placebo |
|---|---|---|
| Baseline MADRS score | 9.86 ± 5.34 | 12.05 ± 6.21 |
| MADRS score at study endpoint | 6.93 ± 5.36 | 9.18 ± 5.67 |
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.
| score on a scale | Lamotrigine | Placebo |
|---|---|---|
| Baseline YMRS scores | 7.30 ± 4.50 | 9.25 ± 5.58 |
| Endpoint YMRS scores | 5.50 ± 2.65 | 7.40 ± 4.03 |
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.
| T scores | Lamotrigine | Placebo |
|---|---|---|
| Neurocognitive Performance (California Verbal Learning Test) | 58.9 ± 14.6 | 52.1 ± 12.5 |
Collected over 18 weeks (two-week baseline assessment phase, 12 week active medication phase, 4 week safety phase after medication discontinuation). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lamotrigine | 0/21 (0%) | 1/21 (4.8%) | 9/21 (42.9%) |
| Placebo | 0/22 (0%) | 1/22 (4.5%) | 9/22 (40.9%) |
| Event | Lamotrigine | Placebo |
|---|---|---|
| HospitalizationPsychiatric disorders | 1/21 | 1/22 |
| Hospitalization (medical) after assaultSurgical and medical procedures | 0/21 | 1/22 |
| Event | Lamotrigine | Placebo |
|---|---|---|
| HeadacheGeneral disorders | 3/21 | 1/22 |
| Erythema / skin discolorationSkin and subcutaneous tissue disorders | 2/21 | 2/22 |
| Papular skin eruptionSkin and subcutaneous tissue disorders | 2/21 | 1/22 |
| NauseaGastrointestinal disorders | 2/21 | 1/22 |
| TremorNervous system disorders | 0/21 | 2/22 |
| PruritusSkin and subcutaneous tissue disorders | 1/21 | 1/22 |
| Flu-like symptomsGeneral disorders | 1/21 | 1/22 |
| Age, Continuous(years) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| Mean | 44.48 ± 11.46 | 44.14 ± 10.13 | 44.30 ± 10.67 |
| Sex: Female, Male(Participants) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| Female | 6 | 7 | 13 |
| Male | 15 | 15 | 30 |
| Race (NIH/OMB)(Participants) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 16 | 20 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Lamotrigine | Placebo | Total |
|---|---|---|---|
| United States | 21 | 22 | 43 |
The record gives a start of Feb 2010, a primary completion of May 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 4 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lamotrigine
Medical University of South Carolina →