NCT00221975

Combination Therapy in Dual Diagnosis Bipolar Rapid Cycling

Combination Therapy in Dual Diagnosis Rapid Cycling Bipolar Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Divalproex	Once a therapeutic blood level of lithium was achieved, Divalproex was initiated at 250 mg twice daily and increased slowly over 5 weeks to a minimum blood level of 50 μg/mL.
DRUG	Lamotrigine	Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over 3 weeks to a minimum blood level of 0.5 mEqlL.
DRUG	Lithium	Subjects who did not respond to the combination of Lithium and Divalproex were then randomly assigned in a 1:1 ratio to adjunctive lamotrigine versus placebo after stratification by illness type (bipolar I versus bipolar II), historical response to lithium (response versus oon-response), and the length of current exposure to the combination treatment with lithium and divalproex (\<2 months versus ≥2 months).

Timeline

• Start date: 2002-07-01
• Primary completion: 2007-06-01
• Completion: 2007-12-01
• First posted: 2005-09-22
• Last updated: 2014-12-03

Locations

1 site across 1 country: United States