Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

NCT ID: NCT03685942

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-16
• Study Completion Date: 2023-09-08

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.

Conditions

Major Depressive Disorder; Unipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

active light therapy (LUMINETTE®)

Intervention Type: DEVICE

light therapy on a portable light visor device

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.

Group Type: PLACEBO_COMPARATOR

placebo light therapy

Intervention Type: DEVICE

placebo portable light visor device

Interventions

active light therapy (LUMINETTE®)

light therapy on a portable light visor device

Intervention Type: DEVICE

placebo light therapy

placebo portable light visor device

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LUCIMED

UNKNOWN

Sponsor Role: collaborator

Centre Psychothérapique de Nancy

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas SCHWITZER

Role: PRINCIPAL_INVESTIGATOR

Centre Psychothérapique de Nancy

Locations

Centre Psychothérapique de Nancy

Laxou, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35301040 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34244279 (View on PubMed)

Other Identifiers

IDRCB 2017-A03349-44

Identifier Type: OTHER

Identifier Source: secondary_id

RIPH 2017-02

Identifier Type: -

Identifier Source: org_study_id