Last reviewed · How we verify
NCT04724668: CHRONO-BE
The Role of the Circadian System in Binge Eating Disorder
NA trial testing Melatonin (3hrs before DLMO) in Binge-Eating Disorder in 43 participants. Completed in 30 May 2025.
30 May 2025
Quick facts
| Lead sponsor | University of Cincinnati |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 43 |
| Start date | 15 January 2021 |
| Primary completion | 30 May 2025 |
| Estimated completion | 30 May 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Melatonin (3hrs before DLMO)
- Placebo (3hrs before DLMO)
- Morning light version 1
- Morning light version 2
Conditions studied
- Binge-Eating Disorder — all drugs for Binge-Eating Disorder →
- Circadian Rhythm Disorders — all drugs for Circadian Rhythm Disorders →
Sponsor
University of Cincinnati
Who can join
Adults 18 to 50, any sex, with Binge-Eating Disorder or Circadian Rhythm Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Home-based dim light melatonin onset assessment among adults with obesity: feasibility and procedural considerations.
Romo-Nava F, Burgess HJ, Blom TJ, Georgiev G, et al · · 2025 · PMID 40917567 · DOI 10.1093/sleepadvances/zpaf047
Verify or expand the search:
- PubMed search for NCT04724668
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04724668 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
- Last refreshed: 18 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04724668.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing