SAD indication approved for antidepressant.(Clinical Rounds)

Extended-release bupropion is the first drug to be approved by the Food and Drug Administration for patients with seasonal affective disorder.

The FDA approved the antidepressant last month for preventing major depressive episodes in patients with a history of seasonal affective disorder (SAD); previously, no drug had been approved for preventing or treating SAD, although antidepressants have been used in such patients.

Bupropion "can help patients with [seasonal affective disorder] to avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter" when daylight hours decrease, Dr. Steven Galson, director of the FDA's Center for Drugs and Research, said in a statement announcing the approval. Bupropion is indicated only for patients who have "a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning," according to the statement. Daily exposure to artificial bright lights and other antidepressant drugs have been used to treat SAD, but light therapy has been more extensively studied.

Extended-release bupropion is marketed as Wellbutrin XL by GlaxoSmithKline. Bupropion is also approved for major depressive disorder and for smoking cessation, and is available in generic formulations.

The approval was based on the results of three double-blind, controlled trials comparing placebo with extended-release bupropion. The trials included 1,042 adults with a 13-season median history of major depressive episode with an autumn-winter seasonal pattern, as defined by DSM-IV criteria. Participants were enrolled in the autumn before the onset of symptoms and started to receive treatment or placebo in September, October, or November, continuing through the winter; treatment was tapered off over 2 weeks in early spring. Patients were started on extended-release bupropion at 150 mg/day for the first week, increasing to 300 mg/day, the approved dosage.

In the combined results, 84% of those on bupropion remained depression-free through the winter, compared with 72% of those on placebo, a significant difference. Another primary efficacy end point--time to onset for recurrence of a ...