Status:
UNKNOWN
Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder: A Study of Dosing With Laser
Lead Sponsor:
Peruvian Clinical Research
Collaborating Sponsors:
NeuroThera
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The Near-infrared transcranial laser therapy (NIR-TLT) is a non-ionizing electromagnetic wave. The NIR-TLT is invisible, penetrates the skin and skull into brain tissue and is non-invasive. The benefi...
Detailed Description
Study purpose: The main aim is to assess and compare the effect(s) of each of the four doses of the Near-infrared Transcranial Laser Therapy (NIR-TLT) on the symptomatology of depression: antidepressa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- Structured psychotherapy focused on treating the subject's depression is permitted if started at least 8 weeks prior to the screening visit.
- Substance dependence or abuse in the past 3 months.
- 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).
- Active suicidal or homicidal ideation (both intention and plan are present), as determined by Columbia-Suicide Severity Rating Scale (C-SSRS) screening.
- 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.
- The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, implantable shunt - Hakim valve).
- 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)
- Recent history of stroke (90 days).
- 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).
- History of dementia, traumatic brain injury (TBI) or any other organic neurological disorder.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05435820
Start Date
July 1 2022
End Date
July 1 2024
Last Update
September 28 2022
Active Locations (1)
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1
Hospital Nacional Hipolito Unanue
Lima, Peru, 15007