Exploring the link between circadian rhythms and binge eating disorder

The Role of the Circadian System in Binge Eating Disorder

This study is testing if getting more morning light and taking melatonin can help people with binge eating disorder by improving their body clocks and eating habits.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Cincinnati (Academic / other)
• Locations: 1 site (Mason, Ohio)
• Trial ID: NCT04724668 on ClinicalTrials.gov

What this trial studies

This research aims to investigate the dysfunction of the circadian system in individuals with binge eating disorder (BED) and assess its potential as a therapeutic target. The study will first characterize circadian system dysfunction in 80 adults, comparing those with BED to a control group without the disorder. Following this, a double-blinded, randomized trial will evaluate the effects of a combination of morning light exposure and melatonin on circadian rhythms and eating behaviors in BED patients. The goal is to determine if advancing the circadian phase can alleviate symptoms of BED.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-50 with a BMI of 30 or higher and a diagnosis of moderate to severe binge eating disorder.

Not a fit: Patients with severe comorbid psychiatric disorders or those currently undergoing pharmacological treatment for BED may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new chronobiological treatments for binge eating disorder, improving patient outcomes.

How similar studies have performed: While there is preliminary evidence suggesting the effectiveness of chronobiological interventions in BED, this specific approach remains novel and untested.

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) \<80
15. Any other clinically relevant reason as judged by the clinician

Control group inclusion criteria:

1. Age 18-50 years, inclusive
2. Female or male;
3. BMI ≥30 kg/m2
4. No current or lifetime history of BED or bulimia nervosa diagnoses confirmed by SCID-5
5. No current (past month) psychiatric diagnosis according to SCID-5, including substance use disorders (caffeine and nicotine allowed)
6. No current psychiatric or psychological treatment, or if receiving treatment dose/intervention stable for ≥ 2 months

Control group exclusion criteria:

1. Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
2. Chronic treatment with BLT or melatonin in the past month
3. Routine shift work (work at night) in the past month
4. Travel across more than 1 time zone in the past two weeks
5. Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year
6. 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
7. Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
8. Pregnant or breastfeeding
9. Participation in a clinical trial in the past month
10. Suspected IQ\<80
11. Any other clinically relevant reason as judged by the clinician

Where this trial is running

Mason, Ohio

• Lindner Center of HOPE / University of Cincinnati — Mason, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Francisco Romo-Nava, MD, PhD — University of Cincinnati/ Lindner Center of HOPE
• Study coordinator: Georgi Georgiev, MSW

Conditions Binge-Eating Disorder; Circadian Rhythm Disorders; Binge eating; Circadian