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

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ClinicalTrials.gov Identifier: NCT03685942
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : December 20, 2021
Sponsor:
Collaborator:
LUCIMED
Information provided by (Responsible Party):
Centre Psychothérapique de Nancy

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Unipolar Depression Device: active light therapy (LUMINETTE®) Device: placebo light therapy Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: active light therapy
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®)
light therapy on a portable light visor device
Placebo Comparator: placebo light therapy
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
placebo portable light visor device


Outcome Measures
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Primary Outcome Measures :
  1. Montgomery-Åsberg depression rating scale (MADRS) [ Time Frame: week 8 ]
    Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27.


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: week 8 ]
    Self reported rating scale measuring quality of sleep

  2. Epworth Sleepiness Scale (ESS) [ Time Frame: week 8 ]
    Self reported rating scale measuring day time sleepiness

  3. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: week 8 ]
    Tool measuring the severity of anxiety symptoms.


Other Outcome Measures:
  1. electroretinogramm [ Time Frame: at inclusion, week 4,8 and 12 ]
    test that measure the functional activity of the retina

  2. Hopkins Verbal Learning Test (HVLT) [ Time Frame: week 10 ]
    test of verbal Learning and memory

  3. Montreal Cognitive Assessment (MoCA) [ Time Frame: week 10 ]
    screening assessment for detecting cognitive impairment

  4. Stroop test [ Time Frame: week 10 ]
    test assessing the ability to inhibit cognitive interference

  5. Trail Making Test (TMT) [ Time Frame: week 10 ]
    test evaluating executive functions

  6. Wechsler Adult Intelligence Scale subtest (WAIS) [ Time Frame: week 10 ]
    test evaluating memory

  7. optical coherence tomography (OCT) [ Time Frame: inclusion and week 12 ]
    evaluation of retinal structure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03685942


Contacts
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Contact: Eve COSKER +33383925034 eve.cosker@cpn-laxou.com
Contact: Tatiana DABROWSKI +33383925349 unic@cpn-laxou.com

Locations
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France
Centre Psychothérapique de Nancy Recruiting
Laxou, France, 54200
Contact: Eve COSKER       eve.cosker@cpn-laxou.com   
Contact: Thomas SCHWITZER       thomas.schwitzer@cpn-laxou.com   
Sponsors and Collaborators
Centre Psychothérapique de Nancy
LUCIMED
Investigators
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Principal Investigator: Thomas SCHWITZER Centre Psychothérapique de Nancy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centre Psychothérapique de Nancy
ClinicalTrials.gov Identifier: NCT03685942    
Other Study ID Numbers: RIPH 2017-02
IDRCB 2017-A03349-44 ( Other Identifier: ANSM (French competent authority) )
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Psychothérapique de Nancy:
light therapy
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders