Status:
COMPLETED
The Role of the Circadian System in Binge Eating Disorder
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Lindner Center of HOPE
Conditions:
Binge-Eating Disorder
Circadian Rhythm Disorders
Eligibility:
All Genders
18-50 years
Phase:
NA
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,...
Detailed Description
The overall objective of the research strategy will be to characterize circadian system dysfunction in BED and its potential as a therapeutic target. The central hypothesis is that a circadian system ...
Eligibility Criteria
Inclusion
- Binge Eating Disorder (BED) group inclusion criteria:
- 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)
- BED exclusion criteria:
- 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
- Control group inclusion criteria:
- Age 18-50 years, inclusive
- Female or male;
- BMI ≥30 kg/m2
- No current or lifetime history of BED or bulimia nervosa diagnoses confirmed by SCID-5
- No current (past month) psychiatric diagnosis according to SCID-5, including substance use disorders (caffeine and nicotine allowed)
- No current psychiatric or psychological treatment, or if receiving treatment dose/intervention stable for ≥ 2 months
- Control group exclusion criteria:
- Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
- Chronic treatment with BLT or melatonin in the past month
- Routine shift work (work at night) in the past month
- Travel across more than 1 time zone in the past two weeks
- Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year
- 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
- Pregnant or breastfeeding
- Participation in a clinical trial in the past month
- Suspected IQ\<80
- Any other clinically relevant reason as judged by the clinician
Exclusion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04724668
Start Date
January 15 2021
End Date
May 30 2025
Last Update
December 18 2025
Active Locations (1)
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1
Lindner Center of HOPE / University of Cincinnati
Mason, Ohio, United States, 45040