The Role of the Circadian System in Binge Eating Disorder

NCT04724668 | Completed DMC FDA Device

• 2 other identifiers: 2020-03451K23MH120503-01A1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Binge eating; Circadian

Outcome Measures

Primary Outcomes (2)

• Phase 1 Dim Light Melatonin Onset (DLMO)

  Difference in mean DLMO (measured in time) between subjects with binge eating disorder (BED) and control subjects without BED.

  Phase 1 baseline (visit 0)

• Phase 2 Dim Light Melatonin Onset (DLMO)

  Differences in DLMO (measured in time) change from baseline to endpoint between two intervention groups will be analyzed using an ANCOVA model with age as a covariate.

  Phase 2 baseline (visit 0) to endpoint, on average one month.

Secondary Outcomes (7)

• Phase 1 Locomotor activity acrophase

  Phase 1 baseline (visit 0)

• Phase 1 Midline Estimating Statistic of Rhythm (MESOR)

  Phase 1 baseline (visit 0)

• Phase 1 MEQ

  Phase 1 baseline (visit 0)

• Phase 1 Association between DLMO and binge eating days/week

  Phase 1 baseline (visit 0)

• Phase 2 Binge eating days/week

  Phase 2 baseline (visit 0) to endpoint, on average one month.

Study Arms (2)

Morning light version+ Melatonin

OTHER

Morning light version and melatonin 3mg capsule (3hrs before DLMO)

Dietary Supplement: Melatonin (3hrs before DLMO); Device: Morning light version 1

Morning light version+ Placebo

OTHER

Morning light version and placebo capsule (3hrs before DLMO)

Dietary Supplement: Placebo (3hrs before DLMO); Device: Morning light version 2

Interventions

Morning light version 2 DEVICE

Morning light version

Morning light version+ Placebo

Melatonin (3hrs before DLMO) DIETARY_SUPPLEMENT

Melatonin 3mg (3hrs before DLMO)

Morning light version+ Melatonin

Placebo (3hrs before DLMO) DIETARY_SUPPLEMENT

Placebo capsule (3hrs before DLMO)

Morning light version+ Placebo

Morning light version 1 DEVICE

Morning light version

Morning light version+ Melatonin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years, inclusive
• Female or male
• BMI ≥30 kg/m2
• Current BED diagnoses by Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria confirmed by Structured Clinical Interview (SCID-5)
• Moderate or severe BED (≥3 binge eating episodes/week in the past 14 days)
• No current pharmacological treatment for BED, or if receiving treatment dose stable for ≥ 2 months
• If receiving psychotherapy, intervention must be stable for ≥ 3 months and agree to continue during the study
• Other psychiatric disorders will be permitted as long as they are not more than moderate in severity
• Using an effective contraceptive method (participants of childbearing potential)

You may not qualify if:

• Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis)
• Current (past month) substance use disorder (caffeine and nicotine allowed)
• Chronic use of bright light therapy (BLT) or melatonin in the past month
• Current contraindication or history of melatonin allergy or non-tolerability;
• Current contraindication or history of BLT non-tolerability
• Significant risk of suicide according to Columbia-Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
• Routine shift work (night work) in the past month
• Travel across more than 1 time zone in the past two weeks
• Current treatment with medication known to affect the circadian system or melatonin measurements, including: B-blockers, hypnotic sedatives, anticoagulants, antidiabetes drugs, oral corticosteroids, and other immunosuppressant medication
• Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
• Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
• Pregnancy or breastfeeding
• Participation in a clinical trial in the past month
• Suspected intelligence quotient (IQ) \<80
• Any other clinically relevant reason as judged by the clinician

Sponsors & Collaborators

• University of Cincinnati: lead
• National Institute of Mental Health (NIMH): collaborator
• Lindner Center of HOPE: collaborator

Study Sites (1)

Lindner Center of HOPE / University of Cincinnati

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Chronobiology Disorders; Bulimia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Nervous System Diseases; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Francisco Romo-Nava, MD, PhD

  University of Cincinnati/ Lindner Center of HOPE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: On the intervention phase 2 (Specific aim 2). Only subjects with BED (n=40) will participate and be randomly assigned to one of two combinations of morning lights and/or melatonin/placebo (20 subjects/each arm). Researchers and participants will be blinded to the intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The specific aims will be completed in a two-phase experimental approach. In the first phase (specific aim 1), subjects with obesity with BED (n=40) and without BED (n=40) will participate in a 2-week longitudinal study. In the second phase (specific aim 2), only BED subjects that complete phase 1 will rollover for a 4-week intervention study.

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 26, 2021
• Study Start: January 15, 2021
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)