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

Centre Psychothérapique de Nancy

Status: Completed

Conditions: Major Depressive Disorder; Unipolar Depression

Treatments: Device: active light therapy (LUMINETTE®); Device: placebo light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03685942

IDRCB 2017-A03349-44 (Other Identifier)

RIPH 2017-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

active light therapy

Experimental group

Description:

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

Treatment:

Device: active light therapy (LUMINETTE®)

placebo light therapy

Placebo Comparator group

Description:

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.

Treatment:

Device: placebo light therapy