Efficacy and Safety of Topiramate in the Treatment of Sleep-Related Eating Disorder
This study is currently recruiting participants.
Verified August 2012 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Information provided by (Responsible Party):
John W. Winkelman, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00606411
First received: January 22, 2008
Last updated: August 7, 2012
Last verified: August 2012
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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 |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:
MedlinePlus related topics:
Eating Disorders
Drug Information available for:
Topiramate
U.S. FDA Resources
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- frequency and severity of sleep-related eating episodes [ Time Frame: every 2 weeks for 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- tolerability of topiramate [ Time Frame: every other week for 10 weeks ] [ Designated as safety issue: Yes ]
- body weight [ Time Frame: every other week for 10 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606411
Contacts
| Contact: Laura Schoerning | 617-783-1496 ext 115 | jwwinkelman@partners.org |
Locations
| United States, Massachusetts | |
| Sleep Health Centers | Recruiting |
| Brighton, Massachusetts, United States, 02135 | |
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
| Principal Investigator: | John W Winkelman, MD, PhD | Brigham and Women's Hospital |
More Information
No publications provided
| Responsible Party: | John W. Winkelman, MD, PhD, Associate Professor of Psychiatry, Harvard Medical School, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00606411 History of Changes |
| Other Study ID Numbers: | BWH-HRC-2007-P-002187 |
| Study First Received: | January 22, 2008 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Sleep-Related Eating Disorder Topiramate Parasomnia |
Additional relevant MeSH terms:
|
Eating Disorders Mental Disorders Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 23, 2013