Actively Recruiting
The Clinical Efficacy of Prefrontal Transcranial Photobiomodulation (tPBM) in Patients With Treatment-Resistant Major Depressive Disorder: A Subgroup Analysis Focusing on Somatic Symptoms
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2026-04-30
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects of moderate-dose transcranial photobiomodulation (t-PBM) at two different frequencies (10 Hz and 40 Hz) in adults with treatment-resistant depression (TRD). The study particularly focuses on the subtype of depression dominated by somatic symptoms. It also aims to explore changes in neurophysiological measures related to brain activity and their connection to symptom improvement. Participants will be randomly assigned to receive t-PBM treatment at either 10 Hz or 40 Hz. Each session involves applying near-infrared light to the prefrontal cortex for 20 minutes, twice weekly over four weeks, totaling eight sessions. The study seeks to compare the effects of these two stimulation frequencies and observe their impact on depressive and somatic symptoms. During the study, participants will undergo clinical assessments before and after treatment, including depression rating scales (HDRS-17, MADRS), somatic symptom questionnaires, sleep quality evaluations, and overall functioning measures. Neurophysiological data will be collected using paired-pulse transcranial magnetic stimulation to assess brain excitability changes. The main outcome is the change in depression severity measured at baseline, after treatment, and at one-month follow-up. Safety and adherence will be monitored throughout the study, which is expected to last at least eight weeks per participant.
CONDITIONS
Brief 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, with a Clinical Global Impression-Severity (CGI-S) score greater than 4 and a 17-item Hamilton Depression Rating Scale (HDRS-17) total score of 18 or higher.
- Must be currently receiving stable antidepressant treatment for at least four weeks but showing inadequate response (treatment-resistant).
- Must have full behavioral capacity, normal intellectual functioning, and be able to understand and sign informed consent.
- Age between 18 and 65 years.
You will not qualify if you...
- Diagnosis of Bipolar Disorder or Schizophrenia.
- Current or recent Substance Use Disorder.
- History of organic brain lesions such as neurodegenerative diseases, epilepsy, or stroke, or any medical condition affecting central nervous system function.
- Abnormal intellectual functioning based on clinical judgment.
- Currently pregnant.
- Any other condition that would make participation unsuitable or prevent informed consent, as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive transcranial photobiomodulation (tPBM) treatment targeting the prefrontal cortex twice a week to help improve symptoms of treatment-resistant depression.
Twice weekly visits for 4 weeks (8 total sessions)
Duration - 4 weeks
Participants are monitored for clinical outcomes and symptom changes after completing the treatment.
1 visit (in-person) at Week 8
Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
J
Jia-Shyun Jeng
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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