Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep-Related Eating Disorder
Intervention: Topiramate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Brigham and Women's Hospital Official(s) and/or principal investigator(s):
John W Winkelman, MD, PhD, Principal Investigator, Affiliation: Brigham and Women's Hospital
Overall contact:
Jessica F Saunders, Phone: 617-783-1496, Ext: 115, Email: SleepResearch@sleephealth.com
Summary
The purpose of the study is to learn about the safety and effectiveness of oral (taken by
mouth) topiramate in treating Sleep-Related Eating Disorder (SRED).
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: frequency and severity of sleep-related eating episodes
Secondary outcome: tolerability of topiramatebody weight
Detailed description:
This is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled,
parallel group, pilot study of topiramate in subjects with Sleep-Related Eating Disorder
(SRED). The primary objective of this study is to investigate the efficacy and safety of
topiramate compared to placebo in the treatment of Sleep-Related Eating Disorder. SRED is a
disorder that consists of out of control eating during the night with little or no awareness
of the events. In this study we are comparing topiramate to placebo. A placebo is a pill that
looks exactly like the study drug, but it does not have any active drug in it. Topamax
(topiramate) is approved by the U. S. Food and Drug Administration (FDA) as a therapy for
epilepsy, but topiramate has not been approved by the FDA for SRED.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adults 18-65
- Diagnosis of SRED
- Must be able to swallow capsules and follow instructions
Exclusion Criteria:
- Women who are pregnant or lactating
- Other sleep disorders
- Kidney or Liver disease
- Night shift workers
- History of non-response or adverse reactions to topiramate
Locations and Contacts
Jessica F Saunders, Phone: 617-783-1496, Ext: 115, Email: SleepResearch@sleephealth.com
Sleep Health Centers, Brighton, Massachusetts 02135, United States; Recruiting
Additional Information
Starting date: January 2008
Ending date: May 2009
Last updated: August 4, 2008
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