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The Role of the Circadian System in Binge Eating Disorder

NCT04724668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-12-18

No results posted yet for this study

Summary

Binge eating disorder (BED) shows prominent circadian features that suggest a delay in circadian phase, and preliminary evidence shows binge eating may be responsive to chronobiological interventions, implicating a circadian system dysfunction in its pathophysiology. What remains lacking, however, is comprehensive knowledge of the characteristics of circadian system dysfunction in BED, and whether this dysfunction represents a therapeutic target in BED. There is therefore a critical need to characterize circadian system dysfunction in BED, and evaluate it as a potential therapeutic target. Without such information, the understanding on the role of the circadian system in BED and its potential as a new therapeutic target will remain limited.

Conditions

  • Binge-Eating Disorder
  • Circadian Rhythm Disorders

Interventions

DIETARY_SUPPLEMENT

Melatonin (3hrs before DLMO)

Melatonin 3mg (3hrs before DLMO)

DIETARY_SUPPLEMENT

Placebo (3hrs before DLMO)

Placebo capsule (3hrs before DLMO)

DEVICE

Morning light version 1

Morning light version

DEVICE

Morning light version 2

Morning light version

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Lindner Center of HOPE

    collaborator OTHER

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Francisco Romo-Nava, MD, PhD · University of Cincinnati/ Lindner Center of HOPE

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724668 on ClinicalTrials.gov