Centre Psychothérapique de Nancy
Laxou, 54200, France
NCT Number: NCT03685942
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Laxou, 54200, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
light therapy on a portable light visor device
placebo portable light visor device
Time frame: week 8
Rating scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total between 0 and 27.
Time frame: week 8
Self reported rating scale measuring quality of sleep
Time frame: week 8
Self reported rating scale measuring day time sleepiness
Time frame: week 8
Tool measuring the severity of anxiety symptoms.
Time frame: at inclusion, week 4,8 and 12
test that measure the functional activity of the retina
Time frame: week 10
test of verbal Learning and memory
Time frame: week 10
screening assessment for detecting cognitive impairment
Time frame: week 10
test assessing the ability to inhibit cognitive interference
Time frame: week 10
test evaluating executive functions
Time frame: week 10
test evaluating memory
Time frame: inclusion and week 12
evaluation of retinal structure
Centre Psychothérapique de Nancy
Other
Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder(LUMIDEP)
Acronym: LUMIDEP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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