Combination Therapy for the Treatment of Bipolar Disorders

• Status: Terminated
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Anticonvulsants; Lamotrigine; Lithium Carbonate; Valproic Acid

Criteria

Inclusion Criteria:

• Bipolar I or II Disorder

• Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months

• Meet criteria for a major depressive episode

Exclusion Criteria:

• History of intolerability of lithium, divalproex, or lamotrigine