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

NCT05435820 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-02

No results posted yet for this study

Summary

Note: This registration is retained as a historical study record. Updated study information and subsequent protocol modifications are available under ClinicalTrials.gov Identifier NCT06934135, which serves as the actively maintained study registration.

The Near-Infrared Transcranial Laser Therapy (NIR-TLT) is a non-invasive intervention that delivers near-infrared light to brain tissue. Photobiomodulation is believed to interact with cytochrome c oxidase, a mitochondrial enzyme involved in cellular energy metabolism, resulting in increased adenosine triphosphate (ATP) production and potential neuroprotective effects.

These mechanisms may promote cellular plasticity and support improvement of depressive symptoms. This study evaluates the safety, tolerability, and potential antidepressant effects of NIR-TLT in adults with Major Depressive Disorder.

Conditions

Interventions

DEVICE

Near-infrared Transcranial Laser Therapy

The treatment consists in exposing bilaterally the frontal brain to Transcranial Laser Therapy, which may enhance ATP production in depressed subjects.

Sponsors & Collaborators

  • Peruvian Clinical Research

    lead OTHER

Principal Investigators

  • William Aguilar Rivera, Dr. · Hospital Nacional Hipolito Unanue

  • Beatrice Macciotta Felices, Dr. · Clinica Vesalio

  • Jeff Huarcaya, Dr. · Hospital Nacional Guillermo Almenara Irigoyen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2026-05-30
Completion
2026-05-30
FDA Device
Yes

Countries

  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05435820 on ClinicalTrials.gov