The Role of the Circadian System in Binge Eating Disorder
Primary Purpose
Binge-Eating Disorder, Circadian Rhythm Disorders
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melatonin (3hrs before DLMO)
Placebo (3hrs before DLMO)
Morning light version 1
Morning light version 2
Sponsored by
About this trial
This is an interventional basic science trial for Binge-Eating Disorder focused on measuring Binge eating, Circadian
Eligibility Criteria
Binge Eating Disorder (BED) group 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
- Using an effective contraceptive method (participants of childbearing potential)
BED exclusion criteria:
- Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis)
- 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
- 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
- Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
- Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
- Pregnancy or breastfeeding
- Participation in a clinical trial in the past month
- Suspected intelligence quotient (IQ) <80
- Any other clinically relevant reason as judged by the clinician
Control group inclusion criteria:
- Age 18-50 years, inclusive
- Female or male;
- BMI ≥30 kg/m2
- No current or lifetime history of BED or bulimia nervosa diagnoses confirmed by SCID-5
- No current (past month) psychiatric diagnosis according to SCID-5, including substance use disorders (caffeine and nicotine allowed)
- No current psychiatric or psychological treatment, or if receiving treatment dose/intervention stable for ≥ 2 months
Control group exclusion criteria:
- Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
- Chronic treatment with BLT or melatonin in the past month
- Routine shift work (work at night) in the past month
- Travel across more than 1 time zone in the past two weeks
- Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year
- 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
- Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
- Pregnant or breastfeeding
- Participation in a clinical trial in the past month
- Suspected IQ<80
- Any other clinically relevant reason as judged by the clinician
Sites / Locations
- Lindner Center of HOPE / University of CincinnatiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Morning light version+ Melatonin
Morning light version+ Placebo
Arm Description
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
Morning light version and placebo capsule (3hrs before DLMO)
Outcomes
Primary Outcome Measures
Phase 1 Dim Light Melatonin Onset (DLMO)
Difference in mean DLMO (measured in time) between subjects with binge eating disorder (BED) and control subjects without BED.
Phase 2 Dim Light Melatonin Onset (DLMO)
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
Phase 1 Locomotor activity acrophase
Difference in mean locomotor activity acrophase (7 days) measured in time between BED and control subjects without BED
Phase 1 Midline Estimating Statistic of Rhythm (MESOR)
Difference in mean MESOR (7 days) measured in time between BED and control subjects without BED
Phase 1 MEQ
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.
Phase 1 Association between DLMO and binge eating days/week
The association between DLMO (measured in time) and binge eating days/week in BED subjects.
Phase 2 Binge eating days/week
Differences in Binge eating days/week from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Phase 2 Locomotor activity acrophase
Differences in locomotor activity acrophase from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Phase 2 baseline (visit 0) to endpoint
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.
Full Information
NCT ID
NCT04724668
First Posted
January 20, 2021
Last Updated
May 8, 2023
Sponsor
University of Cincinnati
Collaborators
National Institute of Mental Health (NIMH), Lindner Center of HOPE
1. Study Identification
Unique Protocol Identification Number
NCT04724668
Brief Title
The Role of the Circadian System in Binge Eating Disorder
Official Title
The Role of the Circadian System in Binge Eating Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute of Mental Health (NIMH), Lindner Center of HOPE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Circadian Rhythm Disorders
Keywords
Binge eating, Circadian
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning light version+ Melatonin
Arm Type
Other
Arm Description
Morning light version and melatonin 3mg capsule (3hrs before DLMO)
Arm Title
Morning light version+ Placebo
Arm Type
Other
Arm Description
Morning light version and placebo capsule (3hrs before DLMO)
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin (3hrs before DLMO)
Intervention Description
Melatonin 3mg (3hrs before DLMO)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (3hrs before DLMO)
Intervention Description
Placebo capsule (3hrs before DLMO)
Intervention Type
Device
Intervention Name(s)
Morning light version 1
Intervention Description
Morning light version
Intervention Type
Device
Intervention Name(s)
Morning light version 2
Intervention Description
Morning light version
Primary Outcome Measure Information:
Title
Phase 1 Dim Light Melatonin Onset (DLMO)
Description
Difference in mean DLMO (measured in time) between subjects with binge eating disorder (BED) and control subjects without BED.
Time Frame
Phase 1 baseline (visit 0)
Title
Phase 2 Dim Light Melatonin Onset (DLMO)
Description
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.
Time Frame
Phase 2 baseline (visit 0) to endpoint, on average one month.
Secondary Outcome Measure Information:
Title
Phase 1 Locomotor activity acrophase
Description
Difference in mean locomotor activity acrophase (7 days) measured in time between BED and control subjects without BED
Time Frame
Phase 1 baseline (visit 0)
Title
Phase 1 Midline Estimating Statistic of Rhythm (MESOR)
Description
Difference in mean MESOR (7 days) measured in time between BED and control subjects without BED
Time Frame
Phase 1 baseline (visit 0)
Title
Phase 1 MEQ
Description
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.
Time Frame
Phase 1 baseline (visit 0)
Title
Phase 1 Association between DLMO and binge eating days/week
Description
The association between DLMO (measured in time) and binge eating days/week in BED subjects.
Time Frame
Phase 1 baseline (visit 0)
Title
Phase 2 Binge eating days/week
Description
Differences in Binge eating days/week from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Time Frame
Phase 2 baseline (visit 0) to endpoint, on average one month.
Title
Phase 2 Locomotor activity acrophase
Description
Differences in locomotor activity acrophase from baseline to endpoint between groups will be analyzed using an ANCOVA model with age as a covariate.
Time Frame
Phase 2 baseline (visit 0) to endpoint, on average one month.
Title
Phase 2 baseline (visit 0) to endpoint
Description
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.
Time Frame
Phase 2 baseline (visit 0) to endpoint, on average one month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Binge Eating Disorder (BED) group 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
Using an effective contraceptive method (participants of childbearing potential)
BED exclusion criteria:
Current severe comorbid psychopathology (i.e; mania, severe major depressive disorder (MDD), psychosis)
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
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
Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
Pregnancy or breastfeeding
Participation in a clinical trial in the past month
Suspected intelligence quotient (IQ) <80
Any other clinically relevant reason as judged by the clinician
Control group inclusion criteria:
Age 18-50 years, inclusive
Female or male;
BMI ≥30 kg/m2
No current or lifetime history of BED or bulimia nervosa diagnoses confirmed by SCID-5
No current (past month) psychiatric diagnosis according to SCID-5, including substance use disorders (caffeine and nicotine allowed)
No current psychiatric or psychological treatment, or if receiving treatment dose/intervention stable for ≥ 2 months
Control group exclusion criteria:
Clinically significant unstable medical conditions as judged by the clinician, including: seizure or neurodegenerative disorders, thyroid conditions, autoimmune disorders, and cardiovascular disease
Chronic treatment with BLT or melatonin in the past month
Routine shift work (work at night) in the past month
Travel across more than 1 time zone in the past two weeks
Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year
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
Current lesions or bleeding in the oral cavity, as it may alter DLMO measurements
Pregnant or breastfeeding
Participation in a clinical trial in the past month
Suspected IQ<80
Any other clinically relevant reason as judged by the clinician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgi Georgiev, MSW
Phone
513-536-0707
Email
georgi.georgiev@lindnercenter.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Romo-Nava, MD, PhD
Organizational Affiliation
University of Cincinnati/ Lindner Center of HOPE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lindner Center of HOPE / University of Cincinnati
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgi Georgiev, MSW
Phone
513-536-0720
Email
georgi.georgiev@lindnercenter.org
First Name & Middle Initial & Last Name & Degree
Georgi Georgiev, MSW
Phone
513-536-0731
Email
Georgi.Georgiev@LindnerCenter.org
First Name & Middle Initial & Last Name & Degree
Francisco Romo-Nava, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
However, individual participant data may be shared with other researchers upon request.
Learn more about this trial
The Role of the Circadian System in Binge Eating Disorder
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