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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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