Trial Information
Summary: Sertraline in the Treatment of Binge Eating Disorder in Overweight Children and Adolescents
The purpose of this study is to examine whether the medication
sertraline (Zoloft) is effective in the treatment of Binge Eating
Disorder (BED) among overweight children and adolescents.
Sertraline is approved by the Food and Drug Administration (FDA)
for the treatment of obsessive-compulsive disorder (OCD) and
depression, but not approved for the treatment of BED. Study
volunteers will be given sertraline for a period of 12 weeks;
subjects who want to continue treatment with sertraline at the
close of the study will be given a referral to an outside physician
for continued treatment. Assessments included in the study are: a
psychiatric and medical evaluation, lab tests (routine blood test,
urinalysis, urine drug screen, vital signs, electrocardiogram
(EKG), pregnancy test (females only).) Participants will be closely
monitored throughout the study by a psychiatrist. GCO#:
01-0429
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
Study volunteers should be 8-18 yrs old; have a clinical
diagnosis of binge eating disorder currently and for at least 6
months prior to study entry; be overweight as compared to others of
same sex, height and age; should be physically healthy without any
serious medical, psychiatric, or neurological illnesses other than
BED; have the ability to communicate meaningfully with the
investigators and be competent to provide written assent; have
parental consent and be English speaking.
Study volunteers should not be on any antidepressants (such as
Elavil, Wellbutrin, Celexa, Anafranil, Norpramin, Luvox, Paxil,
Prozac and Effexor), busipirone (Buspar), lithium, or herbal
preparations with alleged psychiatric effects (such as St. Johns
Wort). Please contact the Study Coordinator below for further
exclusion criteria.
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Contact:
Suah Kim
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Telephone: 212-659-8732
Fax: 212-987-4031
Email:
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Trial listings updated: June 1, 2008 at 5:43:38 AM