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

This study is currently recruiting participants.

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Contacts and Locations

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:

MedlinePlus related topics: Eating Disorders

Drug Information available for: Topiramate

U.S. FDA Resources

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

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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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