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โ† Trials
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Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression

RecruitingNAAges 18 Years - 65 YearsAllTaipei Veterans General Hospital, Taiwan
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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.
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What it tests

  • transcranial photobiomodulation
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Where

1 site
Taipei Veterans General Hospital
Taipei, Taiwan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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