Melatonin Treatment for Night-Eating Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-24

Study Completion Date

2017-04-25

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.

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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.

Conditions

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Night-eating Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Melatonin

A commercially available rapid-release formulation of melatonin (5 mg) capsules to be administered once a day for a total of 8 weeks

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

5mg rapid release melatonin capsule

Placebo

Matching placebo capsules to be administered once a day for a total of 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

matching placebo capsule

Interventions

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Melatonin

5mg rapid release melatonin capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

matching placebo capsule

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes