Status:
COMPLETED
Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Bipolar Disorder
Cocaine Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 outpatien...
Detailed Description
One hundred and twenty (120) adult outpatients with bipolar I, II, not otherwise specified, or cyclothymic disorder and current cocaine dependence will be enrolled. After obtaining informed consent ba...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00280293
Start Date
March 1 2006
End Date
January 1 2010
Last Update
September 26 2013
Active Locations (1)
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1
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8849