Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Completed · Phase 4 · Has a placebo group
Conditions studied: Bipolar Disorder, Cocaine Dependence
In brief
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.
Key facts
- Study ID
- NCT00280293
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 112
- Starts
- 2006-03-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2013-09-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of bipolar I, II, not otherwise specified or cyclothymic disorders
- Currently depressed or mixed mood state
- Ages 18-70 years
- Men or women
- Self-reported cocaine use within 14 days prior to randomization
- English or Spanish speaking
- Baseline Hamilton Depression Rating Scale (HRSD17) score ≥ 10
You may not qualify if…
- Currently taking an enzyme inducing or inhibiting anticonvulsant (e.g. valproic acid, carbamazepine)
- Current severe psychotic features (e.g. daily auditory hallucinations, fixed delusions, severely disorganized thought processes) that require antipsychotic therapy, and that do not appear to be secondary to cocaine use
- Active suicidal ideation (plan and intent) or ≥2 attempts in past 12 months or any attempt in the past month
- Highly unstable medical condition
- Change in concomitant psychiatric medications (e.g. initiated antipsychotic) or in other substance abuse treatment (e.g. began intensive outpatient treatment) within 7 days prior to study entry
- Vulnerable populations (e.g. pregnant or nursing women, prisoners, mentally retarded)
Where it is running
- UT Southwestern Medical Center at Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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