Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

Major Depressive Disorder Clinical Trial

— LUMIDEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685942
• Other study ID #: RIPH 2017-02
• Secondary ID: IDRCB 2017-A0334
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: September 8, 2023

Study information

• Verified date: August 2023
• Source: Centre Psychothérapique de Nancy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 8, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Unipolar Depression

Intervention

Device:
• active light therapy (LUMINETTE®)
light therapy on a portable light visor device
• placebo light therapy
placebo portable light visor device

Locations

Country	Name	City	State
France	Centre Psychothérapique de Nancy	Laxou

Sponsors (2)

Lead Sponsor	Collaborator
Centre Psychothérapique de Nancy	LUCIMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	electroretinogramm	test that measure the functional activity of the retina	at inclusion, week 4,8 and 12
Other	Hopkins Verbal Learning Test (HVLT)	test of verbal Learning and memory	week 10
Other	Montreal Cognitive Assessment (MoCA)	screening assessment for detecting cognitive impairment	week 10
Other	Stroop test	test assessing the ability to inhibit cognitive interference	week 10
Other	Trail Making Test (TMT)	test evaluating executive functions	week 10
Other	Wechsler Adult Intelligence Scale subtest (WAIS)	test evaluating memory	week 10
Other	optical coherence tomography (OCT)	evaluation of retinal structure	inclusion and week 12
Primary	Montgomery-A°sberg depression rating scale (MADRS)	Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27.	week 8
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Self reported rating scale measuring quality of sleep	week 8
Secondary	Epworth Sleepiness Scale (ESS)	Self reported rating scale measuring day time sleepiness	week 8
Secondary	Hamilton Anxiety Rating Scale (HAM-A)	Tool measuring the severity of anxiety symptoms.	week 8