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

ClinicalTrials.gov IDNCT07543328

PhaseNA

Enrollment40

SponsorTaipei Veterans General Hospital, Taiwan

Age18 Years

SexALL

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Conditions studied

Treatment-resistant Depression (TRD), Major Depression Disorder

About this study

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.

Interventions

Device: transcranial photobiomodulation — 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).

Primary outcomes

Change in the 17-item Hamilton Depression Rating Scale (HDRS-17) Total Score (Baseline, Week 4 (Post-treatment), and Week 8 (1-month follow-up after treatment))

Eligibility information

Inclusion Criteria: 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. Exclusion Criteria: 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.

Study locations

Taipei Veterans General Hospital, Taipei, 11217 Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.