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

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Unipolar Depression
• Intervention / Treatment: Device: active light therapy (LUMINETTE®); Device: placebo light therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eve COSKER; Phone Number: +33383925034; Email: eve.cosker@cpn-laxou.com
• Study Contact Backup: Name: Tatiana DABROWSKI; Phone Number: +33383925349; Email: unic@cpn-laxou.com

Study Locations

• France
  • Laxou, France, 54200
    • Centre Psychothérapique de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active light therapy; 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	Device: active light therapy (LUMINETTE®); light therapy on a portable light visor device
Placebo Comparator: placebo light therapy; 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.	Device: placebo light therapy; placebo portable light visor device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Åsberg 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	Self reported rating scale measuring quality of sleep	week 8
Epworth Sleepiness Scale (ESS)	Self reported rating scale measuring day time sleepiness	week 8
Hamilton Anxiety Rating Scale (HAM-A)	Tool measuring the severity of anxiety symptoms.	week 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
electroretinogramm	test that measure the functional activity of the retina	at inclusion, week 4,8 and 12
Hopkins Verbal Learning Test (HVLT)	test of verbal Learning and memory	week 10
Montreal Cognitive Assessment (MoCA)	screening assessment for detecting cognitive impairment	week 10
Stroop test	test assessing the ability to inhibit cognitive interference	week 10
Trail Making Test (TMT)	test evaluating executive functions	week 10
Wechsler Adult Intelligence Scale subtest (WAIS)	test evaluating memory	week 10
optical coherence tomography (OCT)	evaluation of retinal structure	inclusion and week 12

Collaborators and Investigators

• Sponsor: Centre Psychothérapique de Nancy
• Collaborators: LUCIMED
• Investigators: Principal Investigator: Thomas SCHWITZER, Centre Psychothérapique de Nancy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): September 8, 2023
• Study Completion (Actual): September 8, 2023

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: light therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: RIPH 2017-02; IDRCB 2017-A03349-44 (Other Identifier: ANSM (French competent authority))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No