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

Early Phase 1

Completed

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).

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Topiramate	Topiramate or Placebo	Study medication arm, 25-300mg of Topiramate
Placebo	Topiramate or Placebo	Placebo arm of study, 25-300mg of sugar pill

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)	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.
The Clinician Global Impression (CGI) Scale	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 Outcome Measures

Name	Time	Method
HbA1c (%)	Day 1 (First Study Visit) to Day 63 (Final Study Visit)	Change in HbA1c levels from randomization to the end of follow-up.
Average Total Sleep Time (Hours)	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.
Sleep Quality (Visual Analogue Scale or VAS)	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).
The Patient Global Impression (PGI) Scale	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."
Body Weight	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.