Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

NCT03685942 | Completed

• 2 other identifiers: RIPH 2017-02IDRCB 2017-A03349-44
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Unipolar Depression

Keywords

light therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pittsburgh Sleep Quality Index (PSQI)

  week 8

• Epworth Sleepiness Scale (ESS)

  week 8

• Hamilton Anxiety Rating Scale (HAM-A)

  week 8

Other Outcomes (7)

• electroretinogramm

  at inclusion, week 4,8 and 12

• Hopkins Verbal Learning Test (HVLT)

  week 10

• Montreal Cognitive Assessment (MoCA)

  week 10

Study Arms (2)

active light therapy

EXPERIMENTAL

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®)

placebo light therapy

PLACEBO COMPARATOR

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

Interventions

active light therapy (LUMINETTE®) DEVICE

light therapy on a portable light visor device

active light therapy

placebo light therapy DEVICE

placebo portable light visor device

placebo light therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Psychothérapique de Nancy: lead
• LUCIMED: collaborator

Study Sites (1)

Centre Psychothérapique de Nancy

Laxou, 54200, France

Location

Related Publications (2)

• 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.

  PMID: 35301040 DERIVED

• 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.

  PMID: 34244279 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Thomas SCHWITZER

  Centre Psychothérapique de Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: January 16, 2019
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)