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

This study is currently recruiting participants.
Verified March 2016 by John Winkelman, MD, PhD, Massachusetts General Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00606411
First Posted: February 4, 2008
Last Update Posted: March 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital
  Purpose
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: Triple (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 John Winkelman, MD, PhD, 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Previous history of Topiramate or Topamax use for any condition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606411


Contacts
Contact: Leslie Mei 617-643-6026 lamei@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT00606411     History of Changes
Other Study ID Numbers: MGH-2008P000662
First Submitted: January 22, 2008
First Posted: February 4, 2008
Last Update Posted: March 23, 2016
Last Verified: March 2016

Keywords provided by John Winkelman, MD, PhD, Massachusetts General Hospital:
Sleep-Related Eating Disorder
Topiramate
Parasomnia

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents


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