Treatment of refractory bipolar depression
Methods: This multicenter study used a randomized but open-label design. Study drugs (tranylcypromine, 20–100 mg/d, or lamotrigine, 25–400 mg/d) were added to ongoing therapy with a mood stabilizer (lithium, valproate, or carbamazepine at therapeutic levels). The trial’s first stage lasted 10 weeks. In a second phase, nonresponders to the first medication could receive the other drug. Outcome criteria were response (measured with Clinical Global Impressions Scale-Bipolar Version and Inventory for Depressive Symptoms), switch into mania, and study completion.