Bipolar Study in Adults at Least 18 Years of Age

• Status: Completed
• Trial end date: 2004-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Bipolar study of tolerability, clinical response and patient satisfaction

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

• Diagnosis of bipolar I disorder.

• Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.

• If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.

Exclusion Criteria:

• Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.

• Presence of untreated thyroid disease.

• Patient is actively suicidal or homicidal.

• Patient has history of severe hepatic or renal insufficiency.

• Patient is currently participating in another clinical trial.