Authors: Calabrese JR, et al.
Title: Spectrum of activity of lamotrigine in treatment-refractory bipolar disorder.
Reference: Am J Psychiatry 1999;156:1019-23.
Purpose: Assess the safety and efficacy of lamotrigine in patients with bipolar disorder who have inadequately responsed to, or not tolerated, prior pharmacotherapy.
Study design: Open-label, prospective trial.
Follow up: 48 weeks.
Patients: 75 patients presenting with depressed, hypomanic, manic, or mixed states.
(60 received lamotrigine as adjunctive therapy, 15 received lamotrigine as monotherapy).
Treatment: Lamotrigine titrated to a maximum daily dose of 500 mg, with adjustments for concomitant valproate and carbamazepine.
Results: Of depressed patients, 68% showed a marked or moderate response to treatment. Of patients in hypomanic, manic, or mixed states, 84% showed a marked or moderate response to treatment. From baseline, depressed patients exhibited a 42% decrease in HAM-D scores, while hypomanic, manic, or mixed state patients exhibited a 74% decrease in mania scores. The most common drug-related adverse events were dizziness, tremor, somnolence, headache, nausea, and rash. Rash was the most common event resulting in discontinuation (9%), with one patient requiring hospitalization.