CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Lamotrigine +1 moredrug
Likely dose
Lamotrigine 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01015586
NCT01015586Phase 4Completed
CompareCT.gov

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

Medical University of South Carolina·interventional·Posted Nov 18, 2009·Updated Jan 9, 2019

In Brief

A Phase 4 clinical trial evaluating Lamotrigine and Placebo for Alcohol Dependence and 4 related conditions. Completed, enrolled 43 participants across 1 site.

Detailed 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 mood stabilizing medications over a 16 week period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence, Bipolar Disorder, Depression, Mania, Psychosis
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 18, 2009
Enrollment StartFeb 1, 2010
Primary CompletionMay 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 16.6 years ago

Interventions

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