Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of the Circadian System in Binge Eating Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04724668
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Lindner Center of HOPE
Information provided by (Responsible Party):
Francisco Romo-Nava, University of Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Circadian Rhythm Disorders Dietary Supplement: Melatonin (3hrs before DLMO) Dietary Supplement: Placebo (3hrs before DLMO) Device: Morning light version 1 Device: Morning light version 2 Phase 1 Phase 2

Detailed Description:

The overall objective of the research strategy will be to characterize circadian system dysfunction in BED and its potential as a therapeutic target. The central hypothesis is that a circadian system dysfunction (phase delay) plays a role in the pathophysiology of BED, and that advancing the circadian phase will improve BED symptoms. To attain the overall objectives, the following specific aims will be pursued in two phases:

Specific aim 1) To characterize circadian system dysfunction in BED (Phase 1). Circadian system function will be evaluated in 80 adult (18 to 50yrs) obese subjects, 40 with BED and 40 without BED as a control group matched by age, body mass index (BMI), and gender, during a two-week observational phase. Based on preliminary data, the working hypothesis is that DLMO (the primary outcome measure) and secondary circadian parameters (i.e., locomotor activity acrophase) will occur later in the BED group compared with the control group, and a later circadian phase will be associated with worse BED clinical features.

Specific aim 2) To evaluate circadian phase as a predictive biomarker for response to a chronobiological intervention and evidence of circadian system target engagement in BED (Phase 2). A mechanistic clinical trial with a 4-week double-blinded, randomized, sham/placebo controlled study design will evaluate the effect of a combination of morning lights+Melatonin/placebo on the circadian system and eating behavior on 40 BED subjects that complete phase 1. Subjects will be randomized to receive a combination of morning lights at usual wake time + Melatonin(3mg) or placebo (3hr before DLMO). Based on preliminary data, the working hypothesis is that a chronobiological intervention will induce a greater DLMO advance (primary outcome measure), greater decrease in binge eating days/week (secondary outcome measure), and change in exploratory metabolic outcomes. In addition, a later baseline DLMO (secondary outcome) will predict change in binge eating days/week and metabolic parameters in response to a chronobiological intervention.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The specific aims will be completed in a two-phase experimental approach. In the first phase (specific aim 1), obese subjects with BED (n=40) and without BED (n=40) will participate in a 2-week longitudinal study. In the second phase (specific aim 2), only BED subjects that complete phase 1 will rollover for a 4-week intervention study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: On the intervention phase 2 (Specific aim 2). Only subjects with BED (n=40) will participate and be randomly assigned to one of two combinations of morning lights and/or melatonin/placebo (20 subjects/each arm). Researchers and participants will be blinded to the intervention.
Primary Purpose: Basic Science
Official Title: The Role of the Circadian System in Binge Eating Disorder
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Arm Intervention/treatment
Morning light version+ Melatonin
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
Dietary Supplement: Melatonin (3hrs before DLMO)
Melatonin 3mg (3hrs before DLMO)

Device: Morning light version 1
Morning light version

Morning light version+ Placebo
Morning light version and placebo capsule (3hrs before DLMO)
Dietary Supplement: Placebo (3hrs before DLMO)
Placebo capsule (3hrs before DLMO)

Device: Morning light version 2
Morning light version




Primary Outcome Measures :
  1. Phase 1 Dim Light Melatonin Onset (DLMO) [ Time Frame: Phase 1 baseline (visit 0) ]
    Difference in mean DLMO (measured in time) between subjects with binge eating disorder (BED) and control subjects without BED.

  2. Phase 2 Dim Light Melatonin Onset (DLMO) [ Time Frame: Phase 2 baseline (visit 0) to endpoint, on average one month. ]
    Differences in DLMO (measured in time) change from baseline to endpoint between two intervention groups will be analyzed using an ANCOVA model with age as a covariate.


Secondary Outcome Measures :
  1. Phase 1 Locomotor activity acrophase [ Time Frame: Phase 1 baseline (visit 0) ]
    Difference in mean locomotor activity acrophase (7 days) measured in time between BED and control subjects without BED

  2. Phase 1 Midline Estimating Statistic of Rhythm (MESOR) [ Time Frame: Phase 1 baseline (visit 0) ]
    Difference in mean MESOR (7 days) measured in time between BED and control subjects without BED

  3. Phase 1 MEQ [ Time Frame: Phase 1 baseline (visit 0) ]
    Difference in mean Morningness Eveningness Questionnaire scores (MEQ) between BED and control subjects without BED. MEQ score range 18 to 86, lower scores indicate more eveningness, higher scores indicate more morningness.

  4. Phase 1 Association between DLMO and binge eating days/week [ Time Frame: Phase 1 baseline (visit 0) ]
    The association between DLMO (measured in time) and binge eating days/week in BED subjects.

  5. Phase 2 Binge eating days/week [ Time Frame: Phase 2 baseline (visit 0) to endpoint, on average one month. ]
    Differences in Binge eating days/week from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.

  6. Phase 2 Locomotor activity acrophase [ Time Frame: Phase 2 baseline (visit 0) to endpoint, on average one month. ]
    Differences in locomotor activity acrophase from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.

  7. Phase 2 baseline (visit 0) to endpoint [ Time Frame: Phase 2 baseline (visit 0) to endpoint, on average one month. ]
    Differences in MESOR (Midline Estimating Statistic of Rhythm) from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Binge Eating Disorder (BED) group inclusion criteria:

  1. Age 18-50 years, inclusive
  2. Female or male
  3. BMI ≥30 kg/m2
  4. Current BED diagnoses by Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria confirmed by Structured Clinical Interview (SCID-5)
  5. Moderate or severe BED (≥3 binge eating episodes/week in the past 14 days)
  6. No current pharmacological treatment for BED, or if receiving treatment dose stable for ≥ 2 months
  7. If receiving psychotherapy, intervention must be stable for ≥ 3 months and agree to continue during the study
  8. Other psychiatric disorders will be permitted as long as they are not more than moderate in severity
  9. Using an effective contraceptive method (participants of childbearing potential)

BED exclusion criteria:

  1. Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis)
  2. Current (past month) substance use disorder (caffeine and nicotine allowed)
  3. Chronic use of bright light therapy (BLT) or melatonin in the past month
  4. Current contraindication or history of melatonin allergy or non-tolerability;
  5. Current contraindication or history of BLT non-tolerability
  6. Significant risk of suicide according to Columbia-Suicide Severity Rating Scale (CSSRS) or clinical judgment, or suicidal behavior in the past year
  7. Routine shift work (night work) in the past month
  8. Travel across more than 1 time zone in the past two weeks
  9. 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
  10. Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
  11. Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
  12. Pregnancy or breastfeeding
  13. Participation in a clinical trial in the past month
  14. Suspected intelligence quotient (IQ) <80
  15. Any other clinically relevant reason as judged by the clinician

Control group inclusion criteria:

  1. Age 18-50 years, inclusive
  2. Female or male;
  3. BMI ≥30 kg/m2
  4. No current or lifetime history of BED or bulimia nervosa diagnoses confirmed by SCID-5
  5. No current (past month) psychiatric diagnosis according to SCID-5, including substance use disorders (caffeine and nicotine allowed)
  6. No current psychiatric or psychological treatment, or if receiving treatment dose/intervention stable for ≥ 2 months

Control group exclusion criteria:

  1. Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
  2. Chronic treatment with BLT or melatonin in the past month
  3. Routine shift work (work at night) in the past month
  4. Travel across more than 1 time zone in the past two weeks
  5. Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year
  6. 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
  7. Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
  8. Pregnant or breastfeeding
  9. Participation in a clinical trial in the past month
  10. Suspected IQ<80
  11. Any other clinically relevant reason as judged by the clinician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04724668


Contacts
Layout table for location contacts
Contact: Brian Martens, MS 513-536-0707 brian.martens@lindnercenter.org
Contact: Georgi Georgiev, MSW 513-536-0707 georgi.georgiev@lindnercenter.org

Locations
Layout table for location information
United States, Ohio
Lindner Center of HOPE / University of Cincinnati Recruiting
Mason, Ohio, United States, 45040
Contact: Brian Martens, LSW, MS    513-536-0720    Brian.Martens@LindnerCenter.org   
Contact: Georgi Georgiev, MSW    513-536-0731    Georgi.Georgiev@LindnerCenter.org   
Principal Investigator: Francisco Romo-Nava, MD, PhD         
Sponsors and Collaborators
University of Cincinnati
National Institute of Mental Health (NIMH)
Lindner Center of HOPE
Investigators
Layout table for investigator information
Principal Investigator: Francisco Romo-Nava, MD, PhD University of Cincinnati/ Lindner Center of HOPE
Layout table for additonal information
Responsible Party: Francisco Romo-Nava, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT04724668    
Other Study ID Numbers: 2020-0345
1K23MH120503-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: However, individual participant data may be shared with other researchers upon request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Romo-Nava, University of Cincinnati:
Binge eating
Circadian
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronobiology Disorders
Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Nervous System Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants