Near-infrared Radiation-transcranial Photobiomodulation for Major Depressive Disorder

NCT04619121 | Completed

• 1 other identifier: CMUH109-REC3-054
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to be a 3 year, 3 phases project, and will explore the therapeutic effects from near-infrared transcranial photobiomodulation (NIR tPBM) in major depressive disordered human subjects, and it's biological mechanisms in cellular and animal model. However, due to shortage of funding under the pandemics, the project is now modified to start from its clinical part first, and will continue to its basic parts later when funding resources in place.

Conditions

Major Depressive Disorder; Oxidative Stress

Keywords

near-infrared radiation-transcranial photobiomodulation; circadian rhythm; Inflammation; Brain energy metabolism

Outcome Measures

Primary Outcomes (2)

• Change in depressive symptoms (subjective)

  Measured with Beck Depression Rating scale, value from 0 to 63, with higher scores indicating greater severity of depression.

  Measured biweekly up to 12 weeks.

• Change in depressive symptoms (objective)

  Measured with Hamilton Depression rating scale (21-items), value from 0 to 66, with higher scores indicating greater severity of depression.

  Measured biweekly until trial completed, up to 12 weeks.

Secondary Outcomes (2)

• Change in circadian rhythm

  Measured biweekly up to 12 weeks.

• Change in sleep quality

  Measured twice a week up to 12 weeks.

Study Arms (2)

Treatment with real NIR-tPBM on top of standing pharmacotherapy

EXPERIMENTAL

NIR t-PBM to the dorsolateral prefrontal cortex, bilaterally and simultaneously, from 20 minutes to 80 minutes a day, for 8 consecutive weeks.

Device: NIR-tPBM

Sham device on top of standing pharmacotherapy

SHAM COMPARATOR

Sham device with neglectable energy to the dorsolateral prefrontal cortex, bilaterally and simultaneously, from 20 minutes to 80 minutes a day, for 8 consecutive weeks.

Device: Sham device

Interventions

NIR-tPBM DEVICE

The treatment will last for 8 weeks and be bilateral and applied to the frontal areas with one application site on the left side and one on the right side (left and right forehead centered on the frontal eminences and per EEG sites on F3 and F4). Energy is administered with a radiation wavelength of 830 nm. The duration of irradiation is from 20 minutes at each application site (the 2 sites are irradiated at the same time which is equivalent to 20 minutes of total time) to 40 minutes at each site, up to 2 times per day. The treatment will follow these specifications: PBM (IR) irradiance of 33.2 mW/cm2, each treatment window area is 28.7 cm2; PBM (IR) fluence of up to 60 Joules/cm2; energy delivered per session per device up to 1.72 kJ for a total of up to 3.44 kJ.

Also known as: near-infrared transcranial photobiomodulation

Treatment with real NIR-tPBM on top of standing pharmacotherapy

Sham device DEVICE

The sham device is completely identical in appearance, but only emits neglectable energy to the brain.

Also known as: Sham

Sham device on top of standing pharmacotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects may be included in the study only if they meet all of the following criteria:
• The subject should be between at least 18 years of age at screening, but has not had their 76th birthday at screening.
• Diagnosis of major depressive disorder (Based on Diagnostic Statistical Manual-IV or 5 ; diagnosis code: 296.22-296.23、296.32-296.33).
• HAM-D-17 ≥14 and ≤ 25
• Subject Informed Consent obtained in writing in compliance with local regulations prior to enrollment into this study.
• The subject (and caregiver, if applicable) is willing to participate in this study for at least 12 weeks.
• Subjects may only be taking one (1) antidepressant, and will need to be on a stable dose for at least four weeks prior to enrollment.

You may not qualify if:

• Subjects will be excluded from the study for any of the following reasons:
• The subject is pregnant or lactating.
• The subject failed two or more FDA-approved antidepressants during current episode.
• Substance used disorder in the past 6 months.
• Psychotic disorder or psychotic episode (current psychotic episode per assessment).
• Bipolar affective disorder (per assessment).
• Unstable or active medical illness.
• Active suicidal or homicidal ideation.
• 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 directly below any of the procedure sites.
• The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolized AVM, implantable shunt - Hakim valve).
• Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

China Medical University Beigang Hospital

Beigang, Yunlin County, 651012, Taiwan

Location

Related Publications (5)

• Caldieraro MA, Cassano P. Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. J Affect Disord. 2019 Jan 15;243:262-273. doi: 10.1016/j.jad.2018.09.048. Epub 2018 Sep 17.

  PMID: 30248638 BACKGROUND

• Salehpour F, Cassano P, Rouhi N, Hamblin MR, De Taboada L, Farajdokht F, Mahmoudi J. Penetration Profiles of Visible and Near-Infrared Lasers and Light-Emitting Diode Light Through the Head Tissues in Animal and Human Species: A Review of Literature. Photobiomodul Photomed Laser Surg. 2019 Oct;37(10):581-595. doi: 10.1089/photob.2019.4676. Epub 2019 Sep 25.

  PMID: 31553265 BACKGROUND

• Cassano P, Caldieraro MA, Norton R, Mischoulon D, Trinh NH, Nyer M, Dording C, Hamblin MR, Campbell B, Iosifescu DV. Reported Side Effects, Weight and Blood Pressure, After Repeated Sessions of Transcranial Photobiomodulation. Photobiomodul Photomed Laser Surg. 2019 Oct;37(10):651-656. doi: 10.1089/photob.2019.4678.

  PMID: 31647774 BACKGROUND

• Cassano P. Photomedicine and Pharmaceuticals: A Brain New Deal. Photobiomodul Photomed Laser Surg. 2019 Oct;37(10):575-576. doi: 10.1089/photob.2019.4733. Epub 2019 Sep 24. No abstract available.

  PMID: 31549918 BACKGROUND

• Guu TW, Cassano P, Li WJ, Tseng YH, Ho WY, Lin YT, Lin SY, Chang JP, Mischoulon D, Su KP. Wearable, self-administered transcranial photobiomodulation for major depressive disorder and sleep: A randomized, double blind, sham-controlled trial. J Affect Disord. 2025 Mar 1;372:635-642. doi: 10.1016/j.jad.2024.12.065. Epub 2024 Dec 18.

  PMID: 39706483 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Inflammation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ta-Wei Guu, MD

  China Medical University, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: November 6, 2020
• Study Start: December 21, 2020
• Primary Completion: May 31, 2022
• Study Completion: July 31, 2022
• Last Updated: January 4, 2023

Record last verified: 2022-12

Locations

TW (1)