Clinical trial NCT02500017: Melatonin Treatment for Night-Eating Syndrome
Official title: Melatonin Treatment for Night-Eating Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Night-eating Syndrome
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in body weight in kilograms during study duration.
timeFrame: 8 weeks
measure: Change in body mass index (BMI) during study duration
timeFrame: 8 weeks
measure: Change in waist circumference in centimeters during study duration.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Cenk Tek, MD
role: PRINCIPAL_INVESTIGATOR
References: