Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Anticonvulsants; Cocaine; Lamotrigine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)