CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 112 enrolled
Drug / intervention
Lamotrigine +1 moredrug
Likely dose
Not stated in 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/NCT00280293
NCT00280293Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Trial of Lamotrigine add-on Therapy in Outpatients With Bipolar Disorder, Depressed or Mixed Phase and Cocaine Dependence

University of Texas Southwestern Medical Center·interventional·Posted Jan 20, 2006·Updated Sep 26, 2013

In Brief

A Phase 4 clinical trial evaluating Lamotrigine and Placebo for Bipolar Disorder and Cocaine Dependence. Completed, enrolled 112 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if lamotrigine add-on therapy is associated with decreased cocaine craving and improvement in depressive symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence. Additionally, this study is examining whether lamotrigine add-on therapy is associated with decreased cocaine use and the improvement of manic symptom severity than placebo in a group of outpatients with bipolar disorder and cocaine dependence.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Cocaine Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 20, 2006
Enrollment StartMar 1, 2006
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.4 years ago

Interventions

Lamotriginedrug

Lamotrigine

Placebodrug

Placebo