Combination Therapy for the Treatment of Bipolar Disorders

University Hospitals (UH)

Status and phase: Terminated; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Lithium; Drug: Placebo; Drug: Divalproex; Drug: Lamotrigine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00063362

DSIR AT-SO

R21MH062650 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups, including a placebo group

Lithium + divalproex + lamotrigine

Experimental group

Treatment:

Drug: Lamotrigine

Drug: Divalproex

Drug: Lithium

Lithium + divalproex + placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Divalproex

Drug: Lithium