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

Primary Purpose

Major Depressive Disorder, Unipolar Depression

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
active light therapy (LUMINETTE®)
placebo light therapy
Sponsored by
Centre Psychothérapique de Nancy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring light therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Psychothérapique de NancyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

active light therapy

placebo light therapy

Arm 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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2018
Last Updated
August 2, 2023
Sponsor
Centre Psychothérapique de Nancy
Collaborators
LUCIMED
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1. Study Identification

Unique Protocol Identification Number
NCT03685942
Brief Title
Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder
Acronym
LUMIDEP
Official Title
Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Psychothérapique de Nancy
Collaborators
LUCIMED

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Unipolar Depression
Keywords
light therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active light therapy
Arm Type
Experimental
Arm 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
Arm Title
placebo light therapy
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
active light therapy (LUMINETTE®)
Intervention Description
light therapy on a portable light visor device
Intervention Type
Device
Intervention Name(s)
placebo light therapy
Intervention Description
placebo portable light visor device
Primary Outcome Measure Information:
Title
Montgomery-Åsberg depression rating scale (MADRS)
Description
Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self reported rating scale measuring quality of sleep
Time Frame
week 8
Title
Epworth Sleepiness Scale (ESS)
Description
Self reported rating scale measuring day time sleepiness
Time Frame
week 8
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
Tool measuring the severity of anxiety symptoms.
Time Frame
week 8
Other Pre-specified Outcome Measures:
Title
electroretinogramm
Description
test that measure the functional activity of the retina
Time Frame
at inclusion, week 4,8 and 12
Title
Hopkins Verbal Learning Test (HVLT)
Description
test of verbal Learning and memory
Time Frame
week 10
Title
Montreal Cognitive Assessment (MoCA)
Description
screening assessment for detecting cognitive impairment
Time Frame
week 10
Title
Stroop test
Description
test assessing the ability to inhibit cognitive interference
Time Frame
week 10
Title
Trail Making Test (TMT)
Description
test evaluating executive functions
Time Frame
week 10
Title
Wechsler Adult Intelligence Scale subtest (WAIS)
Description
test evaluating memory
Time Frame
week 10
Title
optical coherence tomography (OCT)
Description
evaluation of retinal structure
Time Frame
inclusion and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eve COSKER
Phone
+33383925034
Email
eve.cosker@cpn-laxou.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiana DABROWSKI
Phone
+33383925349
Email
unic@cpn-laxou.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas SCHWITZER
Organizational Affiliation
Centre Psychothérapique de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Psychothérapique de Nancy
City
Laxou
ZIP/Postal Code
54200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eve COSKER
Email
eve.cosker@cpn-laxou.com
First Name & Middle Initial & Last Name & Degree
Thomas SCHWITZER
Email
thomas.schwitzer@cpn-laxou.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35301040
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.
Results Reference
derived
PubMed Identifier
34244279
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.
Results Reference
derived

Learn more about this trial

Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

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