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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2017-A03349-44 | Other Identifier | ANSM (French competent authority) |
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| Name | Class |
|---|---|
| LUCIMED | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active light therapy (LUMINETTE®) | Device | light therapy on a portable light visor device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-AÌŠsberg 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas SCHWITZER | Centre Psychothérapique de Nancy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Psychothérapique de Nancy | Laxou | 54200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35301040 | Derived | 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. | |
| 34244279 |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| placebo light therapy | Device | placebo portable light visor device |
|
| week 8 |
| Hamilton Anxiety Rating Scale (HAM-A) | Tool measuring the severity of anxiety symptoms. | week 8 |
| 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 |
| 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. |