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Completed

NCT Number: NCT00606411

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

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).

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Key information

Conditions

Sleep-Related Eating Disorder Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate or Placebo

Drug

25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules

Other names: Brand Name: Topamax

Primary outcomes

  1. Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)

    Time frame: every 2 weeks for 10 weeks

    Frequency of sleep-related eating episodes was measured as the number of nights a participant had an episode within the previous two weeks. The change was measured by comparing the last study visit (by the participant) from to the baseline results.

  2. The Clinician Global Impression (CGI) Scale

    Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)

    The Clinician Global Impression (CGI) Scale is used by healthcare professionals to assess the overall severity of illness and change in a patient's condition over time. The scale ranges from 1 to 7, 1 being Very much improved and 7 being Very much worse. A participant with a score of 1 or 2 on the Clinician Global Impression scale was considered a "responder."

Secondary outcomes

  1. Body Weight

    Time frame: every other week for 10 weeks

    The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight.

  2. HbA1c (%)

    Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)

    Change in HbA1c levels from randomization to the end of follow-up.

  3. Average Total Sleep Time (Hours)

    Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)

    Average sleep time over the course of the previous two weeks, comparing end results to baseline.

  4. Sleep Quality (Visual Analogue Scale or VAS)

    Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)

    Measured on visual analogue scale (VAS). VAS ranges were as follows: Sleep Quality; 0 = "Poorly" to 100 = "Great," Wakefulness; 0 = "Asleep/Not Awake" to 100 = "Fully Awake," Control; 0 = "No Control Over Eating" to 100 = "Full Control Over Eating," Memory; 0 = "No Memory of Eating" to 100 = "Fully Remember Eating". The change was calculated from baseline to the final study visit (day 63).

  5. The Patient Global Impression (PGI) Scale

    Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)

    A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder."

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Feb 4, 2008
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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