Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02500017
Status:
TERMINATED
Last Update Posted:
2018-01-23
First Post:
2015-07-14
Brief Title:
Melatonin Treatment for Night-Eating Syndrome
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Melatonin Treatment for Night-Eating Syndrome
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty recruiting appropriate participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MLT
Brief Summary:
This is an 8-week randomized double-blind placebo-controlled parallel fixed-dose pilot clinical trial to test the effectiveness of melatonin treatment versus placebo on symptoms of Night Eating Syndrome NES The investigators will also look at the effect of melatonin treatment on weight metabolic parameters and sleep parameters in individuals with NES
Detailed Description:
Night Eating Syndrome NES is a unique disorder characterized by a delayed pattern of food intake in which recurrent episodes of food consumption occurs after the evening meal andor during nocturnal awakenings Diagnostic criteria for NES include 1 recurrent episodes of night eating as manifested by eating after awakening from sleep or by excessive food consumption following the evening meal 2 awareness of those eating episodes and 3 significant distress or impairment caused by the disorder Exclusion criteria are binge-eating disorder or another mental disorder as well as medical disorders or medications that might better explain the disordered eating pattern NES is also more common among patients with insomnia eating disorders and other psychiatric disorders 100 participants with night eating syndrome will be recruited from the general population They will be randomized to either a commercially available rapid-release formulation of melatonin 5 mg or matching placebo capsules that will be administered once a day for a total of 8 weeks Participants will attend a screening appointment a baseline assessment and additional research assessment visits every other week for the 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None