FDA Approves Wellbutrin XL(R) For The Prevention Of Seasonal Major Depressive Episodes
June 13, 2006
The U.S. Food and Drug Administration (FDA) has approved Wellbutrin XL(R) for
the prevention of seasonal major depressive episodes in patients with a
diagnosis of seasonal affective disorder (SAD), a condition affecting about 6
percent of American adults. Wellbutrin XL is the first and only medication
approved to prevent seasonal major depressive episodes.
"Seasonal affective disorder is a serious and often under-diagnosed form of
depression that affects millions of people each year in the United States,"
said Norman E. Rosenthal, M.D., clinical professor of Psychiatry at Georgetown
Medical School and medical director of Capital Clinical Research Associates.
"The FDA approval of Wellbutrin XL for the prevention of seasonal major
depressive episodes in adults diagnosed with SAD is exciting. For the first
time, it may be possible to prevent the predictable onset of SAD with medication
by beginning treatment in the autumn season, prior to experiencing depressive
symptoms."
A combined analysis of three clinical trials showed that Wellbutrin XL reduces
the chance of developing a seasonal major depressive episode by 44 percent.
About Seasonal Affective Disorder
Seasonal affective disorder, also known as major depressive disorder with a
seasonal pattern, is typically characterized by recurring fall or winter onset
of depressive symptoms, with symptoms subsiding during the spring and summer
months. While the exact cause is unknown, SAD is believed to be related to
seasonal variations of light, as well as changes in certain brain chemicals,
which may induce feelings of depression.
"Not surprisingly, the prevalence of SAD is highest in the northern parts
of the United States where winter daylight hours are shorter and people tend to
have less exposure to sunlight," said Rosenthal, who is widely recognized
as the first psychiatrist to investigate SAD, as well as the author of numerous
articles and a popular book on the topic.
Symptoms of SAD may include depressed mood, overeating (with carbohydrate
cravings), weight gain, lethargy and increased sleep.
About the Studies
Although antidepressant medications have been used to treat acute seasonal major
depressive episodes in patients with SAD, these studies with Wellbutrin XL were
among the first pharmacologic studies to explore the possibility of preventing
the onset of autumn-winter depression by starting treatment with an
antidepressant early in the season, prior to experiencing symptoms.
Two placebo-controlled clinical trials were conducted during the 2002-2003
autumn-winter seasons and a third trial during the 2003-2004 autumn-winter
season. A total of 1,042 outpatients were enrolled in the autumn, prior to
experiencing symptoms. The Seasonal Pattern Assessment Questionnaire (SPAQ) was
administered at screening to evaluate the historical pattern and severity of
seasonal depressive symptoms. Subjects received matching placebo or Wellbutrin
XL: the dosing started at 150 mg/day for the first week, with an increase up to
300 mg/day. Treatment was discontinued in the early spring. Primary efficacy
endpoints were depression-free
rates at end-of-treatment and time-to-onset for recurrence of a seasonal major
depressive episode.
In the three studies, patients who enrolled suffered an average of 13 previous
seasonal major depressive episodes. Nonetheless, despite this chronic pattern,
only 41 percent of subjects reported that they had previously been treated for
this condition -- 23 percent with light therapy and 76 percent with
antidepressants. More than half of the subjects reported that their seasonal
symptoms constituted a marked or severe problem for them. A substantial
proportion (61 percent) of subjects reported weight changes across the seasons
(greater than or equal to 8 lbs.) -- primarily in the autumn and winter months.
The results of these three placebo-controlled efficacy studies provide evidence
that Wellbutrin XL is effective in the prevention of seasonal major depressive
episodes in patients with a diagnosis of SAD. The efficacy for the prevention of
a seasonal major depressive episode is demonstrated by the depression-free rates
in patients treated with Wellbutrin XL compared to those treated with placebo.
For all three studies combined, the depression-free rate at the end-of-treatment
was higher in the Wellbutrin XL group than the placebo group (84.3 percent vs.
72 percent), showing a treatment difference of 12.3 percent. The time-to-onset
of a seasonal major depressive episode favored the Wellbutrin XL group over
placebo across the three studies, and was statistically significant in the study
conducted during the 2003-2004 autumn- winter season (p<0.001). Observed
results were consistent across the two seasons over which the three studies were
conducted.
In these studies, the tolerability of Wellbutrin XL was consistent with that
seen in previous trials for major depressive disorder. Common adverse events
were dry mouth, nausea, constipation and flatulence occurring in greater than or
equal to 5 percent of subjects and at a rate exceeding 1.5 times that of
placebo.
IMPORTANT SAFETY INFORMATION
Wellbutrin XL is not for everyone. There is a risk of seizure with Wellbutrin
XL, which increases with higher doses. Taking more than 450 mg/day increases the
chance of serious side effects. People should not use it if they've had a
seizure or eating disorder, or if they abruptly stop using alcohol or sedatives.
People should not take Wellbutrin XL with monoamine oxidase inhibitors (MAOIs),
or medicines that contain bupropion. When used with a nicotine patch or alone,
there is a risk of increased blood pressure, sometimes severe. To reduce risk of
serious side effects, people should tell their doctor if they have liver or
kidney problems.
Other side effects may include flatulence, constipation, weight loss, dry mouth,
nausea, difficulty sleeping, dizziness or sore throat.
Wellbutrin XL is approved only for adults 18 years and over. In some children
and teens, antidepressants increase suicidal thoughts or actions. Whether or not
a person is taking antidepressants, they or their family should call the doctor
right away if they have worsening depression, thoughts of suicide, or sudden or
severe changes in mood or behavior, especially at the beginning of treatment or
after a change in dose (see Medication Guide: What is important information I
should know and share with my family about taking antidepressants? available at http://www.wellbutrin-xl.com).
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U.S. operations in Philadelphia and Research Triangle Park, N.C.
Please consult full prescribing information available at http://www.wellbutrin-xl.com
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