Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression
Recruiting · NCT07543328 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
1 location listed.
- Taipei Veterans General Hospital - Taipei, Taiwan