Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07543328

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

Led by Taipei Veterans General Hospital, Taiwan · Updated on 2026-04-30

40

Participants Needed

1

Research Sites

64 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have a current diagnosis of Major Depressive Disorder (MDD).
  • Clinical severity must be moderate or above, defined as a CGI-S score > 4 and an HDRS-17 total score ≥ 18.
  • Must be currently on stable antidepressant treatment for at least four weeks with inadequate response.
  • Must have full behavioral capacity, normal intellectual functioning, and ability to consent.
Not Eligible

You will not qualify if you...

  • Diagnosis of Bipolar Disorder or Schizophrenia.
  • Current or recent Substance Use Disorder.
  • History of organic brain lesions or medical conditions affecting the central nervous system.
  • Abnormal intellectual functioning based on clinical judgment.
  • Currently pregnant.
  • Any other condition making participation unsuitable or inability to consent.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Actively Recruiting

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Research Team

J

Jia-Shyun Jeng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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