Light Therapy Through the Scalp for Depression That Has Not Responded to Treatment
Tests scalp light therapy at two pulse rates in treatment-resistant depression.
Plain-language title generated from the registry record
Registry title: Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression
Key facts
- Where
- Taipei, TaiwanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07543328, who can take part
Where in Taiwan
- Taipei Veterans General HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Taipei Veterans General Hospital, Taiwan
- Trial code
- NCT07543328
- Record updated
- 30 April 2026
- Original description
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.Read full original descriptionShow less
The Clinical Efficacy of Prefrontal Transcranial Photobiomodulation (tPBM) in Patients With Treatment-Resistant Major Depressive Disorder: A Subgroup Analysis Focusing on Somatic Symptoms
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.
Inclusion: 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: 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; 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).