NCT02500017

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 24, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2017

Completed
Last Updated

January 23, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

July 14, 2015

Last Update Submit

January 18, 2018

Conditions

Night-eating Syndrome

Outcome Measures

Primary Outcomes (1)

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

    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.

    8 weeks

Secondary Outcomes (3)

  • Change in body weight in kilograms during study duration.

    8 weeks

  • Change in body mass index (BMI) during study duration

    8 weeks

  • Change in waist circumference in centimeters during study duration.

    8 weeks

Study Arms (2)

Melatonin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

MelatoninDIETARY_SUPPLEMENT

5mg rapid release melatonin capsule

Melatonin
PlaceboOTHER

matching placebo capsule

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • English speaking
  • Meet DSM-V (Diagnostic and Statistical Manual - version 5) criteria for Night Eating Syndrome (NES)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Night Eating Syndrome

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Cenk Tek, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 16, 2015

Study Start

September 24, 2015

Primary Completion

April 25, 2017

Study Completion

April 25, 2017

Last Updated

January 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)