The Role of the Circadian System in Binge Eating Disorder

Other criteria

• 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