Near-infrared brain light for somatic symptoms in treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Taipei Veterans General Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Jia-Shyun Jeng
• Email: jscheng2@vghtpe.gov.tw
• Phone: +886900015031

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.