(PSYCHIATRIC TIMES) - ROCKVILLE, Md., June 12 — The FDA today approved Wellbutrin XL (bupropion extended release) for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). It was the first drug approved for SAD.
The agency emphasized that Wellbutrin XL, manufactured by GlaxoSmithKline, "is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes." It characterized such patients as those who have "a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning."
Patients diagnosed with SAD have recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. Wellbutrin XL previously was approved for treatment of major depressive disorder.
Depressive episodes in SAD, said the FDA, are defined as depression characterized by the presence of five symptoms such as depressed mood, weight loss or appetite changes, insomnia or hypersomnia, loss of interest in activities, agitation, fatigue, suicidal think or behavior, and feelings of worthlessness or guilt lasting for at least two weeks. These episodes can, however, last as long as six months.
Although patients with SAD may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime, said the agency.
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