Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT05435820
Eligibility Criteria:
Inclusion Criteria:
1. Subjects age at screening will be between 18 and 75 years old (inclusive).
2. Diagnosis of major depressive disorder (Mini International Neuropsychiatric Interview, MINI)
3. QIDS-CR≥12 at screening
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:
1. 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.
2. The subject is pregnant or lactating.
3. 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).
4. Structured psychotherapy focused on treating the subject's depression 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).
9. Active suicidal or homicidal ideation (both intention and plan are present), as determined by Columbia-Suicide Severity Rating Scale (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, 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 Transcranial Magnetic Stimulation).
15. History of dementia, traumatic brain injury (TBI) or any other organic neurological disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05435820
Study Brief:
Protocol Section:
NCT05435820