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Therapeutic Areas: Psychiatry/Psychology
Disease Category: Binge Eating Disorder
Trial Information
Topiramate in the Treatment of Binge-Eating Disorder in Overweight Adults
The purpose of this research program is to see whether the
medication topiramate (Topamax) is effective in the treatment of
Binge Eating Disorder (BED) in overweight adults. Topiramate is
approved by the Food and Drug Administration (FDA) for the
treatment of epileptic seizures, but not approved for the treatment
of BED.
If eligible to participate, program volunteers will be randomly
assigned to receive either topiramate or placebo (a sugar pill with
no active medication) for 16 weeks (each participant will have a
50% chance of being given placebo). After the initial 16-week
period, participants will have the option to enter a 12-week
extension phase in which all participants will be given topiramate
(no one will be given placebo).
Throughout the program, participants will be closely monitored by a
psychiatrist and will also receive: a full psychiatric and medical
evaluation, lab tests (physical exam, routine blood test,
urinalysis, urine drug screen), an electrocardiogram (EKG) and
urine pregnancy tests (females only). GCO# 04-0456PS*
Compensation Provided
Patient Inclusion/Exclusion Criteria:
Participants should be between 18 and 65 years; be overweight as
defined by a body mass index (BMI) of >30 and <50; 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 English
speaking.
Study volunteers should not be on any other forms of psychiatric
medication; those on other medications must be willing to come off
their medication. Please contact the Study Coordinator below for
further exclusion criteria.
Suah Kim
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Phone: (212) 659-8732
Fax: (212) 987-4031
EMail: suah.kim@mssm.edu
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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