Combination Therapy for the Treatment of Bipolar Disorders

Status Terminated

Clinical Trial Summary

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

Clinical Trial Description

Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Bipolar Disorder

Clinical Trial Details

NCT number	NCT00063362
Study type	Interventional
Source	University Hospital Case Medical Center
Contact
Status	Terminated
Phase	Phase 3
Start date	February 2002
Completion date	July 2007

View Details

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