The Role of the Circadian System in Binge Eating Disorder

Description

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

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Study Overview

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Study Details

Study overview

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.

The Role of the Circadian System in Binge Eating Disorder

The Role of the Circadian System in Binge Eating Disorder

Condition
Binge-Eating Disorder
Intervention / Treatment

-

Contacts and Locations

Mason

Lindner Center of HOPE / University of Cincinnati, Mason, Ohio, United States, 45040

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 18-50 years, inclusive
  • 2. Female or male
  • 3. BMI ≥30 kg/m2
  • 4. Current BED diagnoses by Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria confirmed by Structured Clinical Interview (SCID-5)
  • 5. Moderate or severe BED (≥3 binge eating episodes/week in the past 14 days)
  • 6. No current pharmacological treatment for BED, or if receiving treatment dose stable for ≥ 2 months
  • 7. If receiving psychotherapy, intervention must be stable for ≥ 3 months and agree to continue during the study
  • 8. Other psychiatric disorders will be permitted as long as they are not more than moderate in severity
  • 9. Using an effective contraceptive method (participants of childbearing potential)
  • 1. Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis)
  • 2. Current (past month) substance use disorder (caffeine and nicotine allowed)
  • 3. Chronic use of bright light therapy (BLT) or melatonin in the past month
  • 4. Current contraindication or history of melatonin allergy or non-tolerability;
  • 5. Current contraindication or history of BLT non-tolerability
  • 6. Significant risk of suicide according to Columbia-Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
  • 7. Routine shift work (night work) in the past month
  • 8. Travel across more than 1 time zone in the past two weeks
  • 9. 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
  • 10. Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
  • 11. Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
  • 12. Pregnancy or breastfeeding
  • 13. Participation in a clinical trial in the past month
  • 14. Suspected intelligence quotient (IQ) \<80
  • 15. Any other clinically relevant reason as judged by the clinician

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Cincinnati,

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

Study Record Dates

2025-05-30