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Completed

NCT Number: NCT03685942

Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Psychothérapique de Nancy

Laxou, 54200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

active light therapy (LUMINETTE®)

Device

light therapy on a portable light visor device

Placebo light therapy

Device

placebo portable light visor device

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Psychothérapique de Nancy

Other

Collaborators

  • LUCIMED

Registry information

Official study title

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

Acronym: LUMIDEP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 26, 2018
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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