Clinical trial NCT03094260: Light Therapy and Binge Eating Disorder Treatment (BED Light Study)
Official title: Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (\<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 55 years old
* Binge eating disorders or other eating disorders according to DSM V criteria
* Patient with BES score (with " Bing Eating Scale " ) \> 18
* Patient with BMI \> 18.5 kg/m2
* Patient who agrees to be included in the study and who signs the informed consent form
* Patient affiliated to a healthcare insurance plan

Exclusion Criteria:

* Patients with other psychiatric comorbidities, including a disorder bipolar mood
* Unstabilized diabetic patient with or retinopathy
* Patient with sleep disorder (delay or phase inversion)
* Patient with psychotropic treatment unstabilized (except anxiolytic treatment)
* Recent eye surgery or eye problem preventing exposure to bright light.
* Medication making the skin more sensitive to light (eg. Tablets against malaria)
* Patient who does not understand French/is unable to give consent
* Mentally unbalanced patients, under supervision or guardianship
* Patient already included in a research study
* Pregnancy or desire to be pregnant during the study

Primary outcomes:
measure: Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
timeFrame: Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)
Secondary outcomes:
measure: Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
timeFrame: Day-7 to Day-1 period compared to Day23 to Day30 period
measure: Characteristics of hyperphagic access (severity of the disorder)
timeFrame: Day 0
measure: Characteristics of hyperphagic access (severity of the disorder)
timeFrame: Day 30
measure: Characteristics of hyperphagic access (severity of the disorder)
timeFrame: Day 60
measure: Characteristics of hyperphagic access (duration of crisis)
timeFrame: Day 0
measure: Characteristics of hyperphagic access (duration of crisis)
timeFrame: Day 30
measure: Characteristics of hyperphagic access (duration of crisis)
timeFrame: Day 60
measure: Characteristics of hyperphagic access (amount of food ingested )
timeFrame: Day 0
measure: Characteristics of hyperphagic access (amount of food ingested )
timeFrame: Day 30
measure: Characteristics of hyperphagic access (amount of food ingested )
timeFrame: Day 60
measure: Characteristics of hyperphagic access ( evolution of factors triggering)
timeFrame: Day 0
measure: Characteristics of hyperphagic access ( evolution of factors triggering)
timeFrame: Day 30
measure: Characteristics of hyperphagic access ( evolution of factors triggering)
timeFrame: Day 60
measure: Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)
timeFrame: Day 30
measure: Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
timeFrame: Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0)
measure: Symptomatic development of BED
timeFrame: Day 0
measure: Symptomatic development of BED
timeFrame: Day 30
measure: Symptomatic development of BED
timeFrame: Day 60
measure: Evolution of other psychological parameters related to BED
timeFrame: Day 0
measure: Evolution of other psychological parameters related to BED
timeFrame: Day 30
measure: Evolution of other psychological parameters related to BED
timeFrame: Day 60
measure: Evolution of attentional cognitive profiles and impulsivity
timeFrame: Day 0
measure: Evolution of attentional cognitive profiles and impulsivity
timeFrame: Day 30
measure: Evolution of attentional cognitive profiles and impulsivity
timeFrame: Day 60
measure: Evolution of appetite for different categories of food
timeFrame: Day 0
measure: Evolution of appetite for different categories of food
timeFrame: Day 30
measure: Evolution of appetite for different categories of food
timeFrame: Day 60
measure: Biological parameters may be impacted or mediated by part of the treatment efficiency
timeFrame: Day 0
measure: Biological parameters may be impacted or mediated by part of the treatment efficiency
timeFrame: Day 30
measure: Weight (kilogramm)
timeFrame: Day 0
measure: Weight (kilogramm)
timeFrame: Day 30
measure: Weight (kilogramm)
timeFrame: Day 60
measure: Observance rate to light therapy
timeFrame: day1 to day30
Other outcomes:
Locations:
city: Bron
country: France
facility: HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
Study officials:
affiliation: Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
name: Diane MORFIN, MD
role: PRINCIPAL_INVESTIGATOR
References: