FDA Approves First Drug for SAD
Wellbutrin XL Approved for Seasonal Affective Disorder
June 12, 2006 -- The FDA has approved the first drug to treat seasonal affective depressiondepression (SAD), a form of depression that strikes during the year's darker seasons (autumn and winter).
The drug is Wellbutrin XL (bupropion HCL extended-release tablets), which is already approved to treat major depressive disorder.
"Seasonal affective disorder can significantly impair the quality of life of patients with this condition," says the FDA's Steven Galson, MD, MPH, in an FDA news release. Galson directs 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," Galson says.
SAD is characterized by recurrent episodes of major depression that usually coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to six months.
SAD patients may have depressive episodes during other times of the year. But the SAD diagnosis requires that the number of seasonal episodes substantially outnumber the nonseasonal episodes during the individual's lifetime.
Symptoms of major depression include depressed mood, loss of interest, changes in weight and appetite, changes in sleep (sleeping too much or too little), agitation or sluggishness, fatiguefatigue, feeling worthless or guilty, impaired concentration, and suicidal thinking/behavior.
SAD shares those symptoms.
Drug's SAD Studies
Wellbutrin XL's effectiveness in preventing SAD episodes was established in three trials of adults with a history of major depressive disorder in autumn and winter.
Patients either took Wellbutrin XL or a pill containing no medicine (placebo). They didn't know which was which.
Treatment began before the onset of symptoms in the autumn (September to November) and stopped after tapering patients off the drugs for two weeks starting in the first week of spring.
The percentage of patients who were depressiondepression-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 with 72% for those on placebo, according to the FDA.