Authors: Grunze H, et al. Title: Lamotrigine controls bipolar depression without destabilising mood: An analysis of data from placebo controlled trials. Reference: European Neuropsychopharmacology. The Journal of the European College of Neuropsychopharmacology 2003;13(Suppl 4):S265. Purpose: To examine whether lamotrigine causes cycle acceleration or induces manic, hypomanic, or mixed episodes during treatment for the prevention of bipolar depression. Study design: Analysis of data from eight placebo-controlled clinical trials. Follow up: Trial duration ranged from 3 weeks to 18 months. Patients: 1,512 (827 lamotrigine, 685 placebo). Treatment: Adjunctive therapy or monotherapy, dose range 50–500 mg/day. Results: Lamotrigine was not associated with an increased risk of manic, hypomanic, or mixed episodes compared with placebo. During double-blinded phases, 21% of lamotrigine-treated patients received intervention for mania or had an adverse event of mania, compared with 26% of placebo-treated patients. Time to intervention for mania was longer with lamotrigine than placebo.
