drugset / Trial / NCT00221975
Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lamotrigine | Small molecule | 150 mg | — |
| Comparator | Lamotrigine | Small molecule | 200 mg | — |
| Comparator | Divalproex Sodium | Small molecule | — | — |
| Comparator | Lithium | Unknown | — | — |