Combination Therapy for the Treatment of Bipolar Disorders

Condition(s) targeted: Bipolar Disorder

Intervention: Lithium (Drug); Lamotrigine (Drug); Divalproex (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Keming Gao, MD, PhD, Principal Investigator, Affiliation: Case Western Reserve University / University Hospitals of Cleveland

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

Official title: Combination Therapy in Bipolar Rapid Cycling

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

Primary outcome: The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response

Detailed 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.

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Starting date: February 2002
Last updated: December 23, 2013