Depression And Bipolar Disorder

A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.

Inclusion

• Patients must provide written and informed consent.
• Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks.

Exclusion

• Patients must not be suicidal.
• Patients must not have a history of non-response to antidepressant treatment.
• Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry.
• Patients must not have had epilepsy or hypothyroidism.