drugset / Trial / NCT00221975

Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling

NCT00221975

Phase 3 Completed 98 enrolled University Hospitals Cleveland Medical Center
RandomizedParallel-groupTriple-blindDiagnostic

Summary

Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or dependence of cocaine, marijuana and/or alcohol within the past six months. Patients begin treatment with a combination of lithium and divalproex. Once these medications are tolerated, they are randomly assigned to double-blind treatment with lamotrigine or placebo. Patients remain in this study until they experience a marked bimodal response for four consecutive weeks. This study is sponsored by the Stanley Foundation.

Timeline

Start
2002-07
Primary completion
2007-06
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lamotrigine Small molecule 150 mg
Comparator Lamotrigine Small molecule 200 mg
Comparator Divalproex Sodium Small molecule
Comparator Lithium Unknown

Indications