US FDA approves first drug for seasonal depression

The Food and Drug Administration (FDA) has approved GlaxoSmithKline's Wellbutrin XL for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). Wellbutrin XL (bupropion HCL extended release tablets) was previously approved for treatment of major depressive disorder but this is the first drug approved for SAD.

SAD is characterised by recurrent major depressive episodes that coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to 6 months.

Symptoms include: depressed mood; loss of interest; weight loss (or other weight or appetite changes); insomnia or hypersomnia; agitation or psychomotor retardation; fatigue; feelings of worthlessness or guilt; impaired concentration; suicidal thinking or behaviour.

"Seasonal affective disorder can significantly impair the quality of life of patients with this condition," said Dr Steven Galson, director for the FDA's Center of Drugs and Research. "Today's approval can help patients with this condition to avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter."

The effectiveness of Wellbutrin XL for the prevention of SAD episodes was established in three double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter.

In these trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo; for all three studies combined, the overall rate of patients depression-free at the end of treatment was 84% for those on Wellbutrin XL compared to 72% for those on placebo.