NCT07543328Recruiting
Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression
The Clinical Efficacy of Prefrontal Transcranial Photobiomodulation (tPBM) in Patients With Treatment-Resistant Major Depressive Disorder: A Subgroup Analysis Focusing on Somatic Symptoms
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 6 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Diseases
- Depression
- NCT number
- NCT07543328
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 6 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.