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Trial record 10 of 105 for:    Open Studies | "Eating Disorders"

Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Massachusetts General Hospital
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital Identifier:
First received: January 22, 2008
Last updated: March 22, 2016
Last verified: March 2016
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).

Condition Intervention Phase
Sleep-Related Eating Disorder
Drug: Topiramate or Placebo
Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ]

Secondary Outcome Measures:
  • tolerability of topiramate [ Time Frame: every other week for 10 weeks ]
  • body weight [ Time Frame: every other week for 10 weeks ]

Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topiramate
Study medication arm, 25-300mg of Topiramate
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax
Placebo Comparator: Placebo
Placebo arm of study, 25-300mg of sugar pill
Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Previous history of Topiramate or Topamax use for any condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00606411

Contact: Leslie Mei 617-643-6026

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: John W Winkelman, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: John Winkelman, MD, PhD, Associate Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital Identifier: NCT00606411     History of Changes
Other Study ID Numbers: MGH-2008P000662
Study First Received: January 22, 2008
Last Updated: March 22, 2016

Keywords provided by Massachusetts General Hospital:
Sleep-Related Eating Disorder

Additional relevant MeSH terms:
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents processed this record on May 22, 2017