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Circadian Rhythm Interventions for Binge Eating Disorder

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.

Awards & highlights

Study Summary

This trial will comprehensively characterize circadian system dysfunction in BED, and evaluate it as a potential therapeutic target.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ phase 2 baseline (visit 0) to endpoint, on average one month.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1 Dim Light Melatonin Onset (DLMO)

Phase 2 Dim Light Melatonin Onset (DLMO)

Secondary outcome measures

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)

0 / 1Eligibility criteria met

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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

2,783 Previous Clinical Trials

2,689,047 Total Patients Enrolled

Lindner Center of HOPEOTHER

28 Previous Clinical Trials

1,315 Total Patients Enrolled

University of CincinnatiLead Sponsor

428 Previous Clinical Trials

634,306 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are allocated to this research endeavor?

"Affirmative. The clinicaltrials.gov page confirms that this experiment is still actively enrolling patients, beginning on January 15th 2021 and last updated on March 1st 2022; 80 participants need to be sourced from a single medical centre."

Answered by AI

Who is eligible to take part in this medical research?

"Those wishing to participate in this study must have a diagnosis of binge-eating disorder and be between 18 and 50 years old. This clinical trial is aiming to enroll 80 participants."

Answered by AI

Are individuals of advanced age admissible for this research endeavor?

"For inclusion in this trial, participants must be 18 years of age or older and no more than 50."

Answered by AI

Toward what ends is this inquiry striving?

"This trial is aiming to measure Phase 2 baseline (visit 0) with respect to the Dim Light Melatonin Onset (DLMO). The expected timeline for this assessment is roughly one month. Additionally, secondary outcomes being monitored include Morningness Eveningness Questionnaire scores (MEQ), binge eating days/week in BED subjects, and differences in locomotor activity acrophase from initial measurement to endpoint. MEQ ranges between 18-86, where a lower score implies more eveningness tendencies and higher numbers indicate morning preferences."

Answered by AI

Is there an opportunity to join this scientific exploration now?

"Affirmative. An examination of clinicaltrials.gov reveals that this study is currently enrolling patients, having been first posted on January 15th 2021 and recently updated on March 1st 2022. 80 individuals are needed from just one medical site for the trial to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Role of the Circadian System in Binge Eating Disorder

Francisco Romo-Nava 2021. "The Role of the Circadian System in Binge Eating Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04724668.

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