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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606411
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
John Winkelman, MD, PhD, Massachusetts General Hospital

Study Description
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Brief 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).

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
Actual Study Start Date : January 2008
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : November 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: John W Winkelman, MD, PhD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: John Winkelman, MD, PhD, Associate Professor of Psychiatry, Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00606411    
Other Study ID Numbers: MGH-2008P000662
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by John Winkelman, MD, PhD, Massachusetts General Hospital:
Sleep-Related Eating Disorder
Topiramate
Parasomnia
Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Pathologic Processes
Mental Disorders
 Topiramate
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs