TerminatedNot Applicable

Melatonin Treatment for Night-Eating Syndrome

Stopped: Difficulty recruiting appropriate participants

United States2 participantsStarted 2015-09-24

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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

What they're measuring

Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score

Timeframe: 8 weeks

Trial details

NCT IDNCT02500017

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-25

View on ClinicalTrials.gov More Night-eating Syndrome trials