NCT07543328 Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression
| NCT ID | NCT07543328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Veterans General Hospital, Taiwan |
| Condition | Treatment-resistant Depression (TRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-01-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07543328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Treatment-resistant Depression (TRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07543328 currently recruiting?
Yes, NCT07543328 is actively recruiting participants. Contact the research team at jscheng2@vghtpe.gov.tw for enrollment information.
Where is the NCT07543328 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT07543328 clinical trial?
NCT07543328 is sponsored by Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 40 participants.
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