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Melatonin Treatment for Night-Eating Syndrome (MLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500017
Recruitment Status : Terminated (Difficulty recruiting appropriate participants)
First Posted : July 16, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Cenk Tek, Yale University

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.

Condition or disease Intervention/treatment Phase
Night-eating Syndrome Dietary Supplement: Melatonin Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Melatonin Treatment for Night-Eating Syndrome
Actual Study Start Date : September 24, 2015
Actual Primary Completion Date : April 25, 2017
Actual Study Completion Date : April 25, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin
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
5mg rapid release melatonin capsule

Placebo Comparator: Placebo
Matching placebo capsules to be administered once a day for a total of 8 weeks
Other: Placebo
matching placebo capsule




Primary Outcome Measures :
  1. Change in Night Eating Syndrome Symptoms - Night Eating Symptom Scale (NESS) Total Score [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in body weight in kilograms during study duration. [ Time Frame: 8 weeks ]
    Change in body weight in kilograms from baseline to endpoint.

  2. Change in body mass index (BMI) during study duration [ Time Frame: 8 weeks ]
    Change in body weight in kilograms from baseline to endpoint.

  3. Change in waist circumference in centimeters during study duration. [ Time Frame: 8 weeks ]
    Change in waist circumference in centimeters from baseline to endpoint.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500017


Locations
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United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Cenk Tek, MD Yale University
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Responsible Party: Cenk Tek, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT02500017    
Other Study ID Numbers: 1503015417
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All de-identified data resulting from this award involving human subjects will be submitted to the NIMH Data Archive (NDA) - National Database for Clinical Trials Related to Mental Illness (NDCT) The Principal Investigator will work with NDA support staff to plan an appropriate data submission schedule and provide information on the steps for submission and sharing of data. Communication of this data sharing plan to appropriate research staff to ensure the timely submission of data. All human subject data provided will include an NDA Global Unique Identifier (GUID) and will not include personally identifiable information (PII). Analyzed data will be submitted no later than the time of publication. Even if a publication focuses on only part of an analyzed dataset, the entire analyzed dataset will be submitted when the first paper is published. All data made available for public use via NDA will be de-identified data.
Additional relevant MeSH terms:
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Syndrome
Night Eating Syndrome
Disease
Pathologic Processes
Feeding and Eating Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants