Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

Study Overview
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Brief Summary
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This study evaluates the addition of light therapy with LUMINETTE device to usual treatment (antidepressant drug and psychotherapy) in the treatment of Major Depressive Disorder (MDD). Half of the participants will receive active light therapy with LUMINETTE device while the other half will receive placebo light therapy with LUMINETTE placebo device.

Detailed Description
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Major depressive disorder (MDD) is a world wide spread disorder. According to the World health organization, MDD affects more than 300 million people of all ages in the world. Treatments of MDD include pharmacological treatment and psychotherapy. Pharmacological treatments, mostly serotonin selective reuptake inhibitors, have a delayed onset of action, require long-term treatment and have partial efficacy. In fact, only one third of patients respond to the first antidepressant treatment and two-third after multiple trials. So, there is a need for new treatment strategy. Light therapy is a well established non pharmacological treatment of seasonal affective disorder, a clinical subtype of affective disorder characterized by recurrent episodes of depression occurring with a seasonal pattern. Patients are exposed to artificial light for a variable duration and intensity. Although the precise mechanism of bright light therapy remains unknown, it is thought to act through the eyes by activating the suprachiasmatic nucleus, the principal circadian pacemaker.

Official Title
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Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)

Conditions
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Major Depressive Disorder, Unipolar Depression

Intervention / Treatment
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* Device: active light therapy (LUMINETTE®)
* Device: placebo light therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders I-V (DSM-IV), assessed by means of the Mini Neuropsychiatric International Interview (MINI). age between 18 and 60 years. affiliation with a welfare scheme. complete information on the study received and written informed consent signed Exclusion Criteria: diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder) according to Axis I of the DSM-IV, assessed by means of the MINI. absence of routine care for MDD. previous or current LT treatment. seasonal affective disorder. high suicide risk, assessed by means of the MINI ongoing neurological disease. retinal pathology. participation in another study. patient impairment leading to difficulty participating or impossibility or inability to understand the information provided on the study. persons cited in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code: pregnant women, parturient or breastfeeding mothers, persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care under duress, persons admitted to a health or social establishment for other goals than research, minors, adults subject to a legal protection, adults who are unable to express their consent and who are not subject to a legal protection measure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active light therapy<br>Light therapy 1000 lux daily for 30 minutes, as soon as possible after awaking, in preference between 7 and 9 a.m., during 8 weeks in addition to usual treatment | Device: active light therapy (LUMINETTE®)<br>* light therapy on a portable light visor device<br>|
| Placebo Comparator: placebo light therapy<br>People receive usual treatment and use a placebo light therapy device (175 lux) daily for 30 minutes, as soon as possible after awaking, in preference between 7 and 9 a.m. during 8 weeks. | Device: placebo light therapy<br>* placebo portable light visor device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg depression rating scale (MADRS) | Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27. | week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index (PSQI) | Self reported rating scale measuring quality of sleep | week 8 | 
| Epworth Sleepiness Scale (ESS) | Self reported rating scale measuring day time sleepiness | week 8 | 
| Hamilton Anxiety Rating Scale (HAM-A) | Tool measuring the severity of anxiety symptoms. | week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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light therapy