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Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder

Not Applicable
Completed
Conditions
Major Depressive Disorder
Unipolar Depression
Registration Number
NCT03685942
Lead Sponsor
Centre Psychothérapique de Nancy
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria

Inclusion Criteria:<br><br> - MDD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders<br> I-V (DSM-IV), assessed by means of the Mini Neuropsychiatric International Interview<br> (MINI).<br><br> - age between 18 and 60 years.<br><br> - affiliation with a welfare scheme.<br><br> - complete information on the study received and written informed consent signed<br><br>Exclusion Criteria:<br><br> - diagnosis of a progressive psychiatric disorder (except MDD and anxiety disorder)<br> according to Axis I of the DSM-IV, assessed by means of the MINI.<br><br> - absence of routine care for MDD.<br><br> - previous or current LT treatment.<br><br> - seasonal affective disorder.<br><br> - high suicide risk, assessed by means of the MINI<br><br> - ongoing neurological disease.<br><br> - retinal pathology.<br><br> - participation in another study.<br><br> - patient impairment leading to difficulty participating or impossibility or inability<br> to understand the information provided on the study.<br><br> - persons cited in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code:<br> pregnant women, parturient or breastfeeding mothers, persons deprived of their<br> liberty by a judicial or administrative decision, persons under psychiatric care<br> under duress, persons admitted to a health or social establishment for other goals<br> than research, minors, adults subject to a legal protection, adults who are unable<br> to express their consent and who are not subject to a legal protection measure.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Montgomery-A°sberg depression rating scale (MADRS)
Secondary Outcome Measures
NameTimeMethod
Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Hamilton Anxiety Rating Scale (HAM-A)
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