Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression

NCT07543328 | Recruiting

• 2 other identifiers: 2025-08-017AV115B-016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the clinical efficacy of moderate-dose transcranial photobiomodulation (t-PBM) at different frequencies (10 Hz and 40 Hz) in patients with treatment-resistant depression (TRD). It further aims to explore the differential efficacy across various symptom subtypes, with a particular focus on the somatic symptom-dominant subtype. Additionally, this study will collect paired-pulse neurophysiological parameters (e.g., the ratio of cortical inhibition to excitation) to preliminarily explore the neural mechanisms underlying the modulation of cortical excitability by t-PBM intervention, and to analyze their correlation with the magnitude of clinical symptom improvement. The specific aims of this study are as follows: To evaluate the differential efficacy of t-PBM at varying frequencies (10 Hz vs. 40 Hz) in improving clinical depressive symptoms (as measured by scales such as HAM-D and MADRS). To investigate the therapeutic response to t-PBM in patients with the somatic symptom-dominant depression subtype, analyzing its potential suitability for targeting specific symptoms. To explore the changes in paired-pulse TMS parameters (e.g., SICI, ICF, and LICI) before and after t-PBM treatment, gaining preliminary insights into the potential association between its cortical modulatory effects and clinical outcomes.

Conditions

Treatment-resistant Depression (TRD); Major Depression Disorder

Keywords

Photobiomodulation; Major Depression Disorder; tPBM

Outcome Measures

Primary Outcomes (1)

• Change in the 17-item Hamilton Depression Rating Scale (HDRS-17) Total Score

  The 17-item Hamilton Depression Rating Scale (HDRS-17 or HAM-D) is a clinician-administered tool used to assess depression severity, with scores typically ranging from 0-52. Typical HDRS-17 Scoring Interpretation: 0-7: Normal or remission (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23: Very severe depression

  Baseline, Week 4 (Post-treatment), and Week 8 (1-month follow-up after treatment)

Study Arms (2)

10 Hz tPBM

EXPERIMENTAL

Device: transcranial photobiomodulation

40 Hz tPBM

EXPERIMENTAL

Device: transcranial photobiomodulation

Interventions

transcranial photobiomodulation DEVICE

Participants will receive active transcranial photobiomodulation (tPBM) stimulation at a frequency of 10 Hz. The device delivers near-infrared light targeting the prefrontal cortex. Each treatment session lasts for 20 minutes, administered twice a week for four consecutive weeks (totaling 8 sessions).

10 Hz tPBM; 40 Hz tPBM

Eligibility Criteria

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

You may qualify if:

• Must have a current diagnosis of Major Depressive Disorder (MDD).
• The clinical severity must be evaluated by a psychiatrist as moderate or above, defined as a Clinical Global Impression-Severity (CGI-S) score \> 4 and a 17-item Hamilton Depression Rating Scale (HDRS-17) total score ≥ 18.
• Must be currently receiving stable antidepressant treatment for at least four weeks but showing inadequate response (treatment-resistant). This study will be conducted as an add-on therapy.
• Must have full behavioral capacity, normal intellectual functioning, and the ability to comprehend and sign the informed consent form.

You may not qualify if:

• Individuals diagnosed with Bipolar Disorder or Schizophrenia.
• Individuals with current or recent Substance Use Disorder.
• History of organic brain lesions (e.g., neurodegenerative diseases, epilepsy, stroke) or any medical conditions affecting central nervous system function.
• Individuals with abnormal intellectual functioning based on clinical judgment (e.g., suspected intellectual disability, severe learning difficulties).
• Individuals who are currently pregnant (due to limited evidence regarding the safety of tPBM during pregnancy).
• Any other condition that, in the investigator's judgment, would render the participant unable to cooperate, unsuitable for the study, or unwilling to sign the informed consent.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Jia-Shyun Jeng

CONTACT

+886900015031; jscheng2@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the clinical raters assessing the outcome measures (e.g., HDRS-17, MADRS) will be blinded to the assigned tPBM frequency. The device operator will not be blinded as they need to configure the stimulation parameters.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either 10 Hz or 40 Hz active tPBM treatment.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

TW (1)