Melatonin Treatment for Night-Eating Syndrome
| Status: | Terminated |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/24/2018 |
| Start Date: | September 24, 2015 |
| End Date: | April 25, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
New Haven, Connecticut 06508
Principal Investigator: Cenk Tek, MD
Phone: 203-974-7317
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