Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser

Prior treatment

• Structured psychotherapy focused on treating the subject's depression is permitted if started at least 8 weeks prior to the screening visit.
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, implantable shunt - Hakim valve).

Other illness

• History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment).
• Bipolar affective disorder (per MINI assessment).
• Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus).
• 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 in proximity to any of the procedure sites.
• Recent history of stroke (90 days).
• History of dementia, traumatic brain injury (TBI) or any other organic neurological disorder.

Lab values

• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)

Other

• Decrease in Symptoms of Depression Questionnaire (SDQ) self-report from screening to baseline \>=30%, calculated as \[(SDQ screening-88) - (SDQ initial-88) / (SDQ screening-88)\] \>=30/100. A score of 88 is "normal" in SDQ.
• The subject is pregnant or lactating.
• The subject failed more than 2 adequate treatments with FDA approved antidepressants during current episode per Antidepressant Treatment Response Questionnaire (ATRQ) criteria (less than 50% decrease in depressive symptomatology).
• Substance dependence or abuse in the past 3 months.
• Active suicidal or homicidal ideation (both intention and plan are present), as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) screening.
• The subject failed a device-based intervention FDA-approved for the treatment of depression, during the current episode (e.g. less than 50% decrease in depressive symptomatology with Transcranial Magnetic Stimulation).

• Subjects age at screening will be between 18 and 75 years old (inclusive).
• Diagnosis of major depressive disorder (Mini International Neuropsychiatric Interview, MINI)
• QIDS-CR≥12 at screening
• CGI-S ≥4 or higher, i.e., "moderately depressed"
• Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active.
• Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
• The subject is willing to participate in this study for at least 12 weeks.
• Subjects will need to be on stable dose(s) of antidepressants (if taking any) for at least six weeks prior to enrollment.