Near-infrared Radiation-transcranial Photobiomodulation for Major Depressive Disorder
Major Depressive Disorder, Oxidative Stress
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring near-infrared radiation-transcranial photobiomodulation, circadian rhythm, Inflammation, Brain energy metabolism
Eligibility Criteria
Inclusion Criteria:
Subjects may be included in the study only if they meet all of the following criteria:
- The subject should be between at least 18 years of age at screening, but has not had their 76th birthday at screening.
- Diagnosis of major depressive disorder (Based on Diagnostic Statistical Manual-IV or 5 ; diagnosis code: 296.22-296.23、296.32-296.33).
- HAM-D-17 ≥14 and ≤ 25
- Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
- The subject (and caregiver, if applicable) is willing to participate in this study for at least 12 weeks.
- Subjects may only be taking one (1) antidepressant, and will need to be on a stable dose for at least four weeks prior to enrollment.
Exclusion Criteria:
Subjects will be excluded from the study for any of the following reasons:
- The subject is pregnant or lactating.
- The subject failed two or more FDA-approved antidepressants during current episode.
- Structured psychotherapy focused on treating the subject's depression is exclusionary unless the subject has had at least 8 weeks of treatment prior to the screening visit.
- Substance used disorder in the past 6 months.
- Psychotic disorder or psychotic episode (current psychotic episode per assessment).
- Bipolar affective disorder (per assessment).
- Unstable or active medical illness.
- Active suicidal or homicidal ideation.
- The subject has a significant skin condition (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo) on the subject's scalp that is found to be directly below any of the procedure sites.
- The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolized AVM, implantable shunt - Hakim valve).
- Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.
Sites / Locations
- China Medical University Beigang Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Treatment with real NIR-tPBM on top of standing pharmacotherapy
Sham device on top of standing pharmacotherapy
NIR t-PBM to the dorsolateral prefrontal cortex, bilaterally and simultaneously, from 20 minutes to 80 minutes a day, for 8 consecutive weeks.
Sham device with neglectable energy to the dorsolateral prefrontal cortex, bilaterally and simultaneously, from 20 minutes to 80 minutes a day, for 8 consecutive weeks.