Efficacy of Light Therapy Device LUMINETTE® in Major Depressive Disorder
- Conditions
- Major Depressive DisorderUnipolar 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:<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.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Montgomery-A°sberg depression rating scale (MADRS)
- Secondary Outcome Measures
Name Time Method Pittsburgh Sleep Quality Index (PSQI);Epworth Sleepiness Scale (ESS);Hamilton Anxiety Rating Scale (HAM-A)