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Circadian Rhythm Interventions for Binge Eating Disorder (CHRONO-BE Trial)

Phase 1 & 2
Recruiting
Led By Francisco Romo-Nava, MD, PhD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-50 years, inclusive
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2 baseline (visit 0) to endpoint, on average one month.

Summary

This trial tests if exposing patients with Binge Eating Disorder to morning light and giving them a Melatonin pill can help reset their body clock and reduce binge eating. Melatonin is a hormone involved in appetite regulation and food intake, and its supplementation has been studied for its potential to restore balance in cases of circadian disruption. The study focuses on obese adults aged 18-50.

Who is the study for?
This trial is for adults aged 18-50 with a BMI of ≥30 kg/m2 and diagnosed with moderate to severe Binge Eating Disorder (BED) as per DSM-5 criteria. Participants should not be on any new BED medication or have started psychotherapy within the last 2 or 3 months, respectively. Other moderate psychiatric conditions are allowed if stable, and effective contraception must be used by those who can bear children.
What is being tested?
The study tests whether interventions like melatonin taken before the body's natural dim light melatonin onset (DLMO), or exposure to morning light therapy can help manage BED by targeting circadian system dysfunction. It compares these treatments against a placebo to see which is more effective.
What are the potential side effects?
Potential side effects may include sleepiness or grogginess from melatonin, especially when taken at non-typical times, and discomfort or eye strain from morning light therapy. Placebo typically has no side effects but may cause reactions based on individual expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2 baseline (visit 0) to endpoint, on average one month.
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2 baseline (visit 0) to endpoint, on average one month. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1 Dim Light Melatonin Onset (DLMO)
Phase 2 Dim Light Melatonin Onset (DLMO)
Secondary study objectives
Phase 1 Association between DLMO and binge eating days/week
Phase 1 Locomotor activity acrophase
Phase 1 MEQ
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Morning light version+ PlaceboExperimental Treatment2 Interventions
Morning light version and placebo capsule (3hrs before DLMO)
Group II: Morning light version+ MelatoninExperimental Treatment2 Interventions
Morning light version and melatonin 3mg capsule (3hrs before DLMO)

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,931 Previous Clinical Trials
2,744,954 Total Patients Enrolled
Lindner Center of HOPEOTHER
28 Previous Clinical Trials
1,315 Total Patients Enrolled
University of CincinnatiLead Sponsor
439 Previous Clinical Trials
638,668 Total Patients Enrolled
Francisco Romo-Nava, MD, PhDPrincipal Investigator - University of Cincinnati/ Lindner Center of HOPE
University of Cincinnati

Media Library

Morning light version+ Melatonin Clinical Trial Eligibility Overview. Trial Name: NCT04724668 — Phase 1 & 2
Binge Eating Disorder Research Study Groups: Morning light version+ Melatonin, Morning light version+ Placebo
Binge Eating Disorder Clinical Trial 2023: Morning light version+ Melatonin Highlights & Side Effects. Trial Name: NCT04724668 — Phase 1 & 2
Morning light version+ Melatonin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04724668 — Phase 1 & 2
~8 spots leftby May 2025
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