The Role of the Circadian System in Binge Eating Disorder (NCT04724668) | Clinical Trial Compass
CompletedNot Applicable
The Role of the Circadian System in Binge Eating Disorder
United States43 participantsStarted 2021-01-15
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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
Exclusion criteria
✕. Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis)
✕
What they're measuring
1
Phase 1 Dim Light Melatonin Onset (DLMO)
Timeframe: Phase 1 baseline (visit 0)
2
Phase 2 Dim Light Melatonin Onset (DLMO)
Timeframe: Phase 2 baseline (visit 0) to endpoint, on average one month.
. 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