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Completed NCT04724668

The Role of the Circadian System in Binge Eating Disorder

Conditions: Binge-Eating Disorder, Circadian Rhythm Disorders

Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 84
Sponsor: University of Cincinnati

Location: Lindner Center of HOPE / University of Cincinnati Mason Ohio

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.

Eligibility Criteria

Binge Eating Disorder (BED) group inclusion 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) BED exclusion criteria: 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) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04724668). StuddyBuddy aggregates publicly available trial information.