Clinical trial NCT03685942: Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder
Official title: Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Unipolar Depression
Keywords: light therapy
Lead sponsor: Centre Psychothérapique de Nancy
Sponsor class: OTHER
Collaborators: name: LUCIMED
First posted: 2018-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Montgomery-Åsberg depression rating scale (MADRS)
timeFrame: week 8
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: week 8
measure: Epworth Sleepiness Scale (ESS)
timeFrame: week 8
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: week 8
Other outcomes:
measure: electroretinogramm
timeFrame: at inclusion, week 4,8 and 12
measure: Hopkins Verbal Learning Test (HVLT)
timeFrame: week 10
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: week 10
measure: Stroop test
timeFrame: week 10
measure: Trail Making Test (TMT)
timeFrame: week 10
measure: Wechsler Adult Intelligence Scale subtest (WAIS)
timeFrame: week 10
measure: optical coherence tomography (OCT)
timeFrame: inclusion and week 12
Locations:
city: Laxou
country: France
facility: Centre Psychothérapique de Nancy
Study officials:
affiliation: Centre Psychothérapique de Nancy
name: Thomas SCHWITZER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwitzer T, Le Cam S, Cosker E, Vinsard H, Leguay A, Angioi-Duprez K, Laprevote V, Ranta R, Schwan R, Dorr VL. Retinal electroretinogram features can detect depression state and treatment response in adults: A machine learning approach. J Affect Disord. 2022 Jun 1;306:208-214. doi: 10.1016/j.jad.2022.03.025. Epub 2022 Mar 15.
citation: Cosker E, Moulard M, Schmitt S, Angioi-Duprez K, Baumann C, Laprevote V, Schwan R, Schwitzer T. Portable light therapy in the treatment of unipolar non-seasonal major depressive disorder: study protocol for the LUMIDEP randomised controlled trial. BMJ Open. 2021 Jul 9;11(7):e049331. doi: 10.1136/bmjopen-2021-049331.