Authors: Calabrese RJ, et al. Title: Rash in multi-centre trials of lamotrigine in mood disorders: Clinical relevance and management. Reference: J Clin Psychiatry 2002;63:1012-19. Purpose: To determine rates of rash in clinical trials of lamotrigine in patients with unipolar depression or bipolar disorder. Study design: Retrospective analysis of 12 multicenter studies from 1996 to 2001. Follow up: Not applicable. Patients: 1,955 patients were treated with lamotrigine in open-label settings, 1,198 were treated in controlled settings, and 1,056 patients received placebo. Treatment: Dosages of monotherapy or add-on therapy were as per the manufacturers' guidelines. Lamotrigine was usually titrated to 100–500 mg/day, as tolerated. Results: In controlled settings, the rate of benign rash was 8.3% for lamotrigine and 6.4% for placebo. Rates of serious rash were 0% for lamotrigine and comparators, and 0.1% with placebo. In the open-label setting, the overall rate of rash was 13.1% and rate of serious rash was 0.1% with lamotrigine treatment.
