Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder (LUMIDEP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03685942|
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Unipolar Depression||Device: active light therapy (LUMINETTE®) Device: placebo light therapy||Not Applicable|
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 MDD 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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)|
|Actual Study Start Date :||January 16, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||February 2021|
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 (50 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
- Montgomery-Åsberg depression rating scale (MADRS) [ Time Frame: week 8 ]Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27.
- Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: week 8 ]Self reported rating scale measuring quality of sleep
- Epworth Sleepiness Scale (ESS) [ Time Frame: week 8 ]Self reported rating scale measuring day time sleepiness
- Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: week 8 ]Tool measuring the severity of anxiety symptoms.
- electroretinogramm [ Time Frame: at inclusion, week 4,8 and 12 ]test that measure the functional activity of the retina
- Hopkins Verbal Learning Test (HVLT) [ Time Frame: week 10 ]test of verbal Learning and memory
- Montreal Cognitive Assessment (MoCA) [ Time Frame: week 10 ]screening assessment for detecting cognitive impairment
- Stroop test [ Time Frame: week 10 ]test assessing the ability to inhibit cognitive interference
- Trail Making Test (TMT) [ Time Frame: week 10 ]test evaluating executive functions
- Wechsler Adult Intelligence Scale subtest (WAIS) [ Time Frame: week 10 ]test evaluating memory
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685942
|Contact: Eve COSKERemail@example.com|
|Contact: Tatiana DABROWSKIfirstname.lastname@example.org|
|Centre Psychothérapique de Nancy||Recruiting|
|Laxou, France, 54200|
|Contact: Eve COSKER email@example.com|
|Contact: Thomas SCHWITZER firstname.lastname@example.org|
|Principal Investigator:||Thomas SCHWITZER||Centre Psychothérapique de Nancy|