COMPLETED

The Role of the Circadian System in Binge Eating Disorder

Conditions

Binge-Eating Disorder Circadian Rhythm Disorders Binge eating Circadian

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Role of the Circadian System in Binge Eating Disorder

Quick Facts

Study Start:2021-01-15

Study Completion:2025-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04724668

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.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Francisco Romo-Nava, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Cincinnati/ Lindner Center of HOPE

Study Locations (Sites)

Lindner Center of HOPE / University of Cincinnati

Mason, Ohio, 45040

United States

Collaborators and Investigators

Sponsor: University of Cincinnati

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-15

Study Completion Date2025-05-30

Study Record Updates

Study Start Date2021-01-15

Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

Binge eating
Circadian

Additional Relevant MeSH Terms

Binge-Eating Disorder
Circadian Rhythm Disorders