Alcohol DependencePhase 4NCT01015586

Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

A Phase 4 study testing Lamotrigine in people with Alcohol Dependence and Bipolar Disorder, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Alcohol Dependence, Bipolar Disorder, Depression
What is being tested?: Lamotrigine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Feb 2010to Sep 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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:
Lithium level of 0.6 - 1.2 mEq/L
Prescribed daily use of first generation antipsychotic agents including chlorpromazine, fluphenazine, or haloperidol or their injectible depot (decanoate) equivalents at a dose adequate to maintain clinical stability as documented by the subject's outpatient psychiatric provider c) Prescribed daily use of second generation antipsychotic agents including olanzapine, risperidone, paliperidone, quetiapine, aripiprazole, or ziprasidone or their injectible depot equivalent at a dose adequate to maintain clinical stability as documented by the subject's outpatient psychiatric provider
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

Who cannot join

A primary psychiatric diagnosis other than bipolar disorder
Any uncontrolled neurologic condition (e.g. epilepsy) that could confound the results of the study
Any history of Stevens-Johnson syndrome or other severe rash requiring hospitalization
Any history of head injury with loss of consciousness greater than 30 minutes
Any history of learning disability, alcoholic dementia, or electroconvulsive therapy in the past 3 months
Any uncontrolled medical condition that may adversely affect the conduct of the trial or jeopardize the safety of the subject

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Plasma levels of liver transaminases (AST, ALT) greater than 3 times the normal range
Concomitant use of valproic acid
Concomitant use of carbamazepine, oxcarbazepine, phenytoin, primidone, or phenobarbital
Concomitant use of disulfiram, naltrexone, acamprosate, or topiramate
Concomitant use of benzodiazepines or any other medications not allowed per the protocol
Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
Current suicidal or homicidal risk
Baseline scores of more than 35 on the Montgomery-Asberg Depression Rating Scale or more than 16 on the Young Mania Rating Scale

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Neuroscience Division, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence

Conditions: Alcohol Dependence, Bipolar Disorder, Depression, Mania, Psychosis
Being tested: Lamotrigine, Placebo
Keywords: Alcohol, Bipolar Disorder, Manic depression, Addiction, Alcoholism, Cognitive impairment, Executive function, Anxiety, Depression, Mania, Affective disorder, Psychosis, Carbohydrate deficient transferrin, Gammaglutamyltransferase, California Verbal Learning Test, Montgomery Asberg Depression Rating Scale, Young Mania Rating Scale, Timeline Follow Back
Medical subject headings: Alcoholism, Bipolar Disorder, Depression, Mania, Psychotic Disorders, Behavior, Addictive, Cognitive Dysfunction, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LamotrigineDrug
Six week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks
PlaceboDrug
Placebo once daily for 12 weeks

Study groups in NCT01015586
Study group	Role	What they receive
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 Receives: Drug: Lamotrigine
Placebo	Placebo comparator	Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 weeks

Secondary outcomes (6)

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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Study endpoint 12 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Sep 2014

First posted18 Nov 2009 (estimated)
Study startFeb 2010
Primary completionMay 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01015586
Sponsor's protocol ID: HR#19550
Other IDs: K23AA017666
Status last verified: Jan 2019
First submitted: 17 Nov 2009
Last updated: 9 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Trial of Lamotrigine In Individuals With Bipolar Disorder and Comorbid Alcohol Dependence
ClinicalTrials.gov ID: NCT01015586
Acronym / sponsor ID: HR#19550
Conditions: Alcohol Dependence, Bipolar Disorder, Depression, Mania, Psychosis
Keywords: Alcohol, Bipolar Disorder, Manic depression, Addiction, Alcoholism, Cognitive impairment, Executive function, Anxiety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Feb 2010
Primary completion: May 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 18 Nov 2009 (estimated)
Results: Posted 9 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lamotrigine	Experimental	Drug: LamotrigineAdd-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	Drug: PlaceboAdd-on placebo plus pre-existing mood stabilization regimen for 12 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (14 listed)

A primary psychiatric diagnosis other than bipolar disorder
Any uncontrolled neurologic condition (e.g. epilepsy) that could confound the results of the study
Any history of Stevens-Johnson syndrome or other severe rash requiring hospitalization
Any history of head injury with loss of consciousness greater than 30 minutes
Any history of learning disability, alcoholic dementia, or electroconvulsive therapy in the past 3 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LamotrigineSix week titration from 25 mg/day to 200 mg/day, then 200 mg/day maintenance for additional six weeks	Drug	Lamotrigine
PlaceboPlacebo once daily for 12 weeks	Drug	Placebo

Primary outcome

Percent Days Abstinent From Alcohol
Time frame: 12 weeks
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.

6 secondary outcomes

Percent Heavy Drinking Days
Time frame: 12 weeks
Biomarkers of Alcohol Use: Carbohydrate-deficient Transferrin (CDT)
Time frame: 12 weeks after randomization
Biomarkers of Alcohol Use: Gamma-glutamyltransferase (GGT)
Time frame: 12 weeks after randomization
Montgomery-Asberg Depression Rating Scale (MADRS) Score
Time frame: Baseline and 12 weeks
Young Mania Rating Scale (YMRS) Scores
Time frame: Baseline and 12 weeks
Neurocognitive Performance (California Verbal Learning Test)
Time frame: Study endpoint 12 weeks after randomization

Results and safety

Results posted to the registry on 9 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lamotrigine	21	14
Placebo	22	11

Primary outcome: Percent Days Abstinent From Alcohol

Time frame: 12 weeks. Mean (Standard Deviation). Unit: Percentage of days abstinent

Measure	Lamotrigine n = 20	Placebo n = 17
Value	78.7 (30.0)	80.1 (28.4)

Population analysed: Analysis is of modified intention to treat (ITT) sample comprised of all randomized subjects who returned for at least one study visit after randomization.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 weeks (two-week baseline assessment phase, 12 week active medication phase, 4 week safety phase after medication discontinuation). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lamotrigine	1 of 21 (4.8%)	9 of 21 (42.9%)	0 of 21
Placebo	1 of 22 (4.5%)	9 of 22 (40.9%)	0 of 22

Limitations and caveats (from the sponsor): Relatively small sample size, suboptimal retention rate (58% of all randomized subjects)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bryan K Tolliver, MD, PhD principal investigator

Medical University of South Carolina

Kathleen T Brady, M.D., Ph.D. study director

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lamotrigine in people with Alcohol Dependence and Bipolar Disorder, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Days Abstinent From Alcohol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01015586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.