Melatonin Treatment for Night-Eating Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Melatonin Treatment for Night-Eating Syndrome

Conditions
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Night-eating Syndrome

Intervention / Treatment
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* Dietary Supplement: Melatonin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years of age English speaking Meet DSM-V (Diagnostic and Statistical Manual - version 5) criteria for Night Eating Syndrome (NES) Exclusion Criteria: Unable to provide informed consent Presence of alcohol/substance dependence Presence of other eating disorders such as Binge Eating Disorder, Anorexia Nervosa. 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) Women who are pregnant or breastfeeding Allergy or hypersensitivity to melatonin

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>A commercially available rapid-release formulation of melatonin (5 mg) capsules to be administered once a day for a total of 8 weeks | Dietary Supplement: Melatonin<br>* 5mg rapid release melatonin capsule<br>|
| Placebo Comparator: Placebo<br>Matching placebo capsules to be administered once a day for a total of 8 weeks | Other: Placebo<br>* matching placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight in kilograms during study duration. | Change in body weight in kilograms from baseline to endpoint. | 8 weeks | 
| Change in body mass index (BMI) during study duration | Change in body weight in kilograms from baseline to endpoint. | 8 weeks | 
| Change in waist circumference in centimeters during study duration. | Change in waist circumference in centimeters from baseline to endpoint. | 8 weeks |