Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency
|Bipolar Disorder Cocaine Dependence||Drug: Lamotrigine Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Days of Cocaine Use [ Time Frame: 10 weeks ]Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.
- Positive Urine Drug Screens [ Time Frame: 10 weeks ]Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.
- Depression Score on the Hamilton Rating Scale For Depression [ Time Frame: 10 weeks ]Total score on the Hamilton Rating Scale for Depression at week 10 visit or at last assessment if participant withdrew early(total score values range 0 - 52. A higher score indicates more severe depression.
- Dollars Spent [ Time Frame: 10 weeks ]Dollars spent on cocaine during the 7 days of week 10, or at last assessment if participant withdrew early, based on self report.
|Study Start Date:||March 2006|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: 1
Active Comparator: 2
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 baseline assessment measures will be administered including the Structured Clinical Interview for Diagnostic Statistical Manual-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 Psychobiology of Recovery in Depression-III Somatic Symptom Scale (PRD-III)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 Cocaine Craving Questionaire (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280293
|United States, Texas|
|UT Southwestern Medical Center at Dallas|
|Dallas, Texas, United States, 75390-8849|
|Principal Investigator:||E. Sherwood Brown, M.D., Ph.D.||UT Southwestern Medical Center at Dallas|