Lamotrigine Add-on Therapy for Bipolar Disorder and Cocaine Dependency
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Cocaine Dependence
Intervention: Lamotrigine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): E. Sherwood Brown, M.D., Ph.D., Principal Investigator, Affiliation: UT Southwestern Medical Center at Dallas
Overall contact: Sharon M Sowell, B.A., Phone: 214-645-6962, Email: Sharon.Sowell@UTSouthwestern.edu
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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Trial of Lamotrigine Add-on Therapy in Outpatients With Bipolar Disorder, Depressed or Mixed Phase and Cocaine Dependence
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Timeline FollowbackCocaine Craving Questionnaire Urine drug screens Hamilton Rating Scale for Depression Quick Inventory of Depressive Symptomatology-SR Young Mania Rating Scale Barratt Impulsiveness Scale Rey Auditory Verbal Learning Test STROOP color-word task The Addiction Severity Index PRD-III Somatic Symptom Scale
Detailed description:
One hundred and twenty (120) adult outpatients with bipolar I, II, NOS, or cyclothymic
disorder and current cocaine dependence will be enrolled. After obtaining informed consent
baseline assessment measures will be administered including the Structured Clinical Interview
for DSM-IV Axis I Disorders. Drug use will be assessed using the timeline-followback method
to quantify days and amount of drug use, urine drug screens will also be obtained and craving
will be assessed with the Cocaine Craving Questionnaire. Mood symptoms will be quantified at
each weekly visit with the Hamilton Rating Scale for Depression (17-item version), Quick
Inventory of Depressive Symptomatology-SR (QIDS-SR), and Young Mania Rating Scale (YMRS).
Impulsivity will be assessed at weeks 0, 5 and 10 with the Barratt Impulsiveness Scale (BIS,
Barratt et al 1983). Cognition will be assessed at weeks 0, 5, and 10 with the Rey Auditory
Verbal Learning Test (RAVLT) and STROOP color-word task. The Addiction Severity Index (ASI)
will be administered at baseline and week 10. The PRD-III Somatic Symptom Scale will be
administered every 2 weeks to track side effects. A study psychiatrist will assess
participant-reported side effects weekly. Women of childbearing age will be given a test to
rule out pregnancy. Subjects will be randomized and Lamotrigine therapy or identical
appearing placebo add-on therapy in a double- blind fashion will be initiated at 25 mg/day
and increased to 200 mg/day using a slow upward titration over 5 weeks (as outlined by
Calabrese et al 2000 and following the package insert) to minimize risk of side effects such
as rash. After that time additional increases in 100 mg/day increments to a maximum of 400
mg/day can be made if the medication is well tolerated and HRSD scores have decreased by ≤
40% from baseline or CCQ scores have decreased ≤ 25% from baseline or participants continue
to use cocaine in past week based on either self-report or urine drug screen results.
Subjects will be assessed weekly for mood and drug use/craving and every four weeks for
cognition over 10 weeks. All of the assessments may be provided in Spanish, if needed.
Additionally, a Spanish-speaking research assistant and study psychiatrist will be available
at all times.
Subjects will be paid $30 for each visit and given $2 restaurant coupons. Parking tokens ($3)
or bus passes ($2) will also be provided. Concomitant medications will be managed with an
algorithm that discourages but, if necessary, allows changes in other psychiatric
medications. At the completion of 10 weeks of blinded therapy participants in both groups
will be offered 4 weeks of open-label therapy either continuing at the week 10 dose in those
on active medication or slowly titrated upward for those on placebo. Participants will be
assessed with the HRSD, QIDS-SR, YMRS, CCQ and drug use quantified at biweekly appointments
with the RAVLT and STROOP also administered at week 14 exit. Participants will not be paid
for participation in the open-label phase but bus tokens and parking passes will be
provided.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of bipolar I, II, NOS 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 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)
Locations and Contacts
Sharon M Sowell, B.A., Phone: 214-645-6962, Email: Sharon.Sowell@UTSouthwestern.edu
UT Southwestern Medical Center at Dallas, Dallas, Texas 75390-8849, United States; Recruiting E. Sherwood Brown, M.D., Ph.D., Phone: 214-645-6950, Email: Sherwood.Brown@UTSouthwestern.edu
Additional Information
Psychoneuroendocrinology Research Group - UT Southwestern Medical Center at Dallas
Starting date: March 2006
Last updated: August 31, 2006
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