F32 NULL NULL
Conditions
Interventions
None listed
Sponsors
PTHERA LLC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects age at screening will be between 18 and 75 years old (inclusive). 2. Diagnosis of major depressive disorder (MINI) 3. QIDS-C = 12 at screen 4. CGI-S = 4 or higher, i.e., “moderately depressed” 5. Women of child-bearing potential must use a double-barrier method for birth control (e.g. condoms plus spermicide) if sexually active. 6. Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study. 7. The subject is willing to participate in this study for at least 12 weeks. 8. Subjects will need to be on stable dose(s) of antidepressants (if taking any) for at least six weeks prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Decrease in SDQ self-report from screen to baseline >=30%, computed as [(SDQscreen-88) – (SDQbaseline-88) / (SDQscreen-88)] >=30/100. A score of 88 is “normal” at SDQ. 2. The subject is pregnant or lactating. 3. The subject failed more than 2 adequate treatment with FDA-approved antidepressants during current episode - less than 50% decrease in depressive symptomatology. 4. Structured psychotherapy focused on treating the subject’s depression (i.e. CBT or IPT) is permitted if started at least 8 weeks prior to the screening visit. 5. Substance dependence or abuse in the past 3 months. 6. History of a psychotic disorder or psychotic episode (current psychotic episode per MINI assessment). 7. Bipolar affective disorder (per MINI assessment). 8. Unstable medical illness, defined as any medical illness which is not well-controlled with standard-of-care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension). 9. Active suicidal or homicidal ideation (both intention and plan are present), as determined by C-SSRS screening. 10. 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. 11. The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt – Hakim valve). 12. 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) 13. Recent history of stroke (90 days). 14. 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 TMS, ECT or VNS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Compare the effect (s) of each of the five doses of NIR-TLT on the symptoms of depression: antidepressant effect. -Compare safety and tolerability at each dose. NAME OF THE RESULT: Clinical evaluation of major depression PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 10 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| -Compare the effect (s) of each of the five doses of NIR-TLT on the symptoms of depression: antidepressant effect. -Compare safety and tolerability at each dose. NAME OF THE RESULT: Clinical evaluation of major depression PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 10 weeks;-Compare the effect (s) of each of the five doses of NIR-TLT on brain electrophysiology. -Compare the effect (s) of each of the five doses of NIR-TLT on mitochondrial function. -To study the correlations (correlate) the antidepressant effects, brain electrophysiology and mitochondrial function of each of the NIR-TLT doses. NAME OF THE RESULT: Compare antidepressant effects. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 10 weeks | — |
Countries
Peru
Outcome results
None listed