Bipolar Disorder Study for Men and Women

• Status: Completed
• Trial end date: 2005-12-14
• Target enrollment: 0
• Participant gender: All

Summary

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Lamotrigine

Criteria

Inclusion Criteria:

• Patients must provide written and informed consent

• Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks

• Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior

Exclusion Criteria:

• Patients must not be suicidal

• Patients must not have a history or 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