Melatonin Treatment for Night-Eating Syndrome

Night-eating Syndrome Clinical Trial

— MLT  

Official title:

Melatonin Treatment for Night-Eating Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02500017
• Other study ID #: 1503015417
• Status: Terminated
• Phase: N/A
• First received: July 14, 2015
• Last updated: January 18, 2018
• Start date: September 24, 2015
• Est. completion date: April 25, 2017

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 and/or 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. 18 - 65 years of age

2. English speaking

3. Meet DSM-V (Diagnostic and Statistical Manual - version 5) criteria for Night Eating Syndrome (NES)

Exclusion Criteria:

1. Unable to provide informed consent

2. Presence of alcohol/substance dependence

3. Presence of other eating disorders such as Binge Eating Disorder, Anorexia Nervosa.

4. Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)

5. Women who are pregnant or breastfeeding

6. Allergy or hypersensitivity to melatonin

Related Conditions & MeSH terms

• Night-eating Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Melatonin
5mg rapid release melatonin capsule

Other:
• Placebo
matching placebo capsule

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score	Change in total score for the Night Eating Symptom Scale (NESS) from baseline to endpoint. Scores range from 0-52. Lower scores are better than higher scores.	8 weeks
Secondary	Change in body weight in kilograms during study duration.	Change in body weight in kilograms from baseline to endpoint.	8 weeks
Secondary	Change in body mass index (BMI) during study duration	Change in body weight in kilograms from baseline to endpoint.	8 weeks
Secondary	Change in waist circumference in centimeters during study duration.	Change in waist circumference in centimeters from baseline to endpoint.	8 weeks