Near-infrared brain light 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
This will test whether twice-weekly near‑infrared transcranial photobiomodulation at 10 Hz or 40 Hz can reduce depressive and physical (somatic) symptoms in people with treatment‑resistant depression who are already on antidepressants.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Taipei Veterans General Hospital, Taiwan Government |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07543328 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-group trial will enroll about 40 adults with treatment‑resistant major depressive disorder and randomly assign them to receive tPBM at either 10 Hz or 40 Hz twice weekly for four weeks as an add-on to stable antidepressant therapy. Pre- and post-treatment clinical measures will include HDRS-17, MADRS, PHQ-15, DSSS, sleep quality, and overall functioning to capture depressive and somatic symptom change. Paired-pulse TMS will be used to record cortical excitability and inhibition parameters to explore neurophysiological mechanisms and their correlation with clinical response. The study aims to compare frequency-specific efficacy and to determine whether patients with somatic-dominant symptom profiles receive greater benefit.
Who should consider this trial
Good fit: Adults with major depressive disorder of at least moderate severity (HDRS‑17 ≥18 and CGI‑S >4) who have had an inadequate response to antidepressants despite a stable medication regimen for at least four weeks and who can attend twice-weekly visits and provide informed consent.
Not a fit: People with bipolar disorder, schizophrenia, current or recent substance use disorder, significant neurological disease (e.g., epilepsy, stroke, neurodegeneration), abnormal intellectual functioning, or those not on a stable antidepressant regimen are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a safe, low-side-effect adjunctive therapy that reduces depressive and somatic symptoms for people with treatment-resistant depression.
How similar studies have performed: Small pilot studies and preliminary reports suggest tPBM can reduce depressive symptoms, but direct comparisons of stimulation frequencies and targeted effects for somatic-dominant TRD remain largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei
- Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jia-Shyun Jeng
- Email: jscheng2@vghtpe.gov.tw
- Phone: +886900015031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.