Authors: Calabrese JR, et al. Title: A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamictal 602 Study Group. Reference: J Clin Psychiatry 1999;60:79-88. Purpose: To evaluate lamotrigine monotherapy in the treatment of bipolar depression. Study design: Double-blinded, placebo-controlled, multicenter study. Follow up: 7 weeks. Patients: 195 outpatients experiencing a major depressive episode (66 lamotrigine 50 mg/day, 63 lamotrigine 200 mg/day, and 66 placebo). Treatment: Lamotrigine 50 or 200 mg/day, or placebo as monotherapy. Results: Lamotrigine 200 mg/day demonstrated significant antidepressant efficacy compared with placebo. Improvements were seen by week 3. Adverse events and safety were similar across treatment groups, with the exception of a higher rate of headache in the lamotrigine groups.
