Actively Recruiting
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
On this page
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
Eligibility Criteria
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.
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
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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