Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
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ClinicalTrials.gov Identifier: NCT00606411 |
Recruitment Status :
Completed
First Posted : February 4, 2008
Last Update Posted : August 14, 2019
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Condition or disease | Intervention/treatment | Phase |
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Sleep-Related Eating Disorder | Drug: Topiramate or Placebo | Early Phase 1 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Topiramate
Study medication arm, 25-300mg of Topiramate
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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
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Drug: Topiramate or Placebo
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Other Name: Brand Name: Topamax |
- frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ]
- tolerability of topiramate [ Time Frame: every other week for 10 weeks ]
- body weight [ Time Frame: every other week for 10 weeks ]

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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 |
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

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
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | John W Winkelman, MD, PhD | Massachusetts General Hospital |
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 |
Sleep-Related Eating Disorder Topiramate Parasomnia |
Disease Feeding and Eating Disorders Pathologic Processes Mental Disorders |
Topiramate Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs |