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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
25-300 mg tablets of topiramate and matching placebo, placed in blinded capsules
Massachusetts General Hospital
Boston, Massachusetts, United States
Change in Frequency of Sleep-related Eating Episodes (Time Frame: Comparing Final Study Visit to Baseline)
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.
Time frame: every 2 weeks for 10 weeks
The Clinician Global Impression (CGI) Scale
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."
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)
Body Weight
The change in body weight in the study participants was calculated comparing the participant's last study visit to their baseline weight.
Time frame: every other week for 10 weeks
HbA1c (%)
Change in HbA1c levels from randomization to the end of follow-up.
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Average Total Sleep Time (Hours)
Average sleep time over the course of the previous two weeks, comparing end results to baseline.
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
Sleep Quality (Visual Analogue Scale or VAS)
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).
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Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit)
The Patient Global Impression (PGI) Scale
A participant with a score of 1 or 2 on the Patient Global Impression scale was considered a "responder."
Time frame: Day 1 (First Study Visit) to Day 63 (Final Study Visit) (assessed at last study visit)