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NCT06934135

Near-infrared Transcranial Laser Therapy in Subjects With Major Depressive Disorder

Sponsor: NeuroThera DE

View on ClinicalTrials.gov

Summary

Major depressive disorder (MDD) is a leading cause of disability worldwide, and many patients do not achieve adequate benefit from current treatments. Transcranial photobiomodulation (tPBM) is a non-invasive neuromodulation technique that delivers near-infrared (808 nm) light through the scalp to frontal brain regions involved in mood regulation. Preclinical and early clinical studies suggest that tPBM may improve symptoms of depression and enhance cortical function. This randomized, sham-controlled, parallel-group trial evaluates the efficacy, safety, and neural effects of tPBM in adults with MDD. Participants are assigned to one of four groups: Continuous Wave, Medium Dose (CW), Continuous Wave, Low Dose (CW\_LOW), Pulsed Wave (PW), or Sham treatment. Interventions are delivered 3 times a week for 6 weeks (total of 18 sessions) to bilateral frontal scalp sites (AF3/F3 and AF4/F4). The primary outcome is change in depressive symptoms measured by the Hamilton Depression Rating Scale (HAMD-17) from baseline to the end of treatment (Week 6, Visit 18). Secondary outcomes include changes in self-reported depression scales (QIDS, SDQ), regional brain glucose metabolism measured by FDG-PET, and resting-state EEG markers. Safety and tolerability are assessed throughout the trial, including adverse events, scalp/site reactions, and suicidality screening. This study will provide proof-of-concept evidence for the clinical efficacy and mechanistic effects of tPBM in major depression and will inform the design of larger, multicenter clinical trials.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-08-24

Completion Date

2025-08-01

Last Updated

2026-09-24

Healthy Volunteers

Conditions

Depression Depressive Disorder Depressive Disorder, Major

Interventions

DEVICE

Bilateral Near-Infrared Transcranial Photobiomodulation (tPBM)

808-nm near-infrared laser light is delivered through a headset forming approximately uniform, round beams of approximately 12 cm² at each of 2 bilateral frontal scalp sites (EEG positions AF3/F3 and AF4/F4; approximately 24 cm² total), irradiated simultaneously. Arms: (1) CW, Medium Dose, approximately 300 mW/cm² average irradiance (3.6 W per site; 7.2 W both sites); (2) CW\_LOW, approximately 50 mW/cm² (0.6 W per site; 1.2 W both sites); (3) PW, 42 Hz, 33% duty cycle, peak approximately 900 mW/cm² (10.8 W per site; 21.6 W both sites), average approximately 300 mW/cm² (3.6 W per site; 7.2 W both sites); (4) Sham, identical device and procedural cues, no therapeutic emission (0 mW/cm²). Sessions lasted 429 seconds, 3 times weekly for 6 weeks (18 sessions). Sham duration and procedures matched the active arms to maintain blinding.

Inclusion Criteria: The age of subjects in the study will be between 18 and 75 years (inclusive). Diagnosis of Major Depressive Disorder (MINI). QIDS-C ≥12 at screening. CGI-S ≥4 or higher, i.e., "moderately depressed." Women of childbearing potential must use a double-barrier method of birth control (e.g., condoms plus spermicides) if sexually active. Written informed consent was obtained from the subject in accordance with local regulations prior to enrollment in this study. The subject is willing to participate in this study for at least 12 weeks. Subjects must have been on stable doses of antidepressants (if taking any) for at least six weeks before enrollment. Exclusion Criteria: A decrease in self-reported SDQ from screening to baseline ≥30%, calculated as \[((SDQ\_screening-88) - (SDQ\_baseline-88)) / (SDQ\_screening-88)\] ≥30/100. A score of 88 is considered "normal" on the SDQ. The subject is pregnant or breastfeeding. The subject has failed more than 2 adequate treatments with FDA-approved antidepressants during the current episode according to ATRQ criteria (less than a 50% reduction in depressive symptoms). Structured psychotherapy focused on treating depression (i.e., CBT or IPT) is allowed if initiated at least 8 weeks before the screening visit. Substance dependence or abuse in the past 3 months. History of a psychotic disorder or psychotic episode (current psychotic episode as per MINI evaluation). Bipolar affective disorder (as determined by MINI evaluation). Unstable medical illness, is defined as any medical condition that is not well controlled with standard care medications (e.g., insulin for diabetes mellitus, HCTZ for hypertension). Active suicidal or homicidal ideation (both intent and plan are present), as determined by C-SSRS screening. The subject has a significant skin condition (e.g., hemangioma, scleroderma, psoriasis, rash, open wound, or tattoo) on the scalp near any of the procedure sites. The subject has any type of implant in the head (e.g., stent, clipped aneurysm, embolized AVM, implantable shunt - Hakim valve). Any use of light-activated medications (photodynamic therapy) within 14 days prior to study enrollment (in the U.S.: Visudyne (verteporfin) - for age-related macular degeneration; Aminolevulinic Acid - for actinic keratosis; 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 (within 90 days). The subject had a failed intervention with an FDA-approved device for depression treatment during the current episode (e.g., less than a 50% reduction in depressive symptoms with TMS, ECT, or VNS). History of dementia, traumatic brain injury (TBI), or any other organic neurological disorder.

Locations (2)

Clinica Vesalio

Lima, Lima Province, Peru

Hospital Nacional Guillermo Almenara Irigoyen