Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder
- Conditions
- Major Depressive DisorderUnipolar Depression
- Registration Number
- NCT03685942
- Lead Sponsor
- Centre Psychothérapique de Nancy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Montgomery-Åsberg depression rating scale (MADRS) 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
Name Time Method Pittsburgh Sleep Quality Index (PSQI) week 8 Self reported rating scale measuring quality of sleep
Hamilton Anxiety Rating Scale (HAM-A) week 8 Tool measuring the severity of anxiety symptoms.
Epworth Sleepiness Scale (ESS) week 8 Self reported rating scale measuring day time sleepiness
Trial Locations
- Locations (1)
Centre Psychothérapique de Nancy
🇫🇷Laxou, France
Centre Psychothérapique de Nancy🇫🇷Laxou, France