Treatment-resistant Depression (TRD)NCT07543328
Transcranial Photobiomodulation (tPBM) for Somatic Symptoms in Treatment-Resistant Depression
A study testing transcranial photobiomodulation in people with Treatment-resistant Depression (TRD) and Major Depression Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment-resistant Depression (TRD), Major Depression Disorder
- What is being tested?
- transcranial photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jan 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Jia-Shyun Jeng, +886-900-015-031, jscheng2@vghtpe.gov.tw
About this study
Official title: 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:
Read more
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.
Read the detailed description
This study aims to investigate the potential efficacy of transcranial photobiomodulation (tPBM) as an adjunctive antidepressant treatment in patients with treatment-resistant depression (TRD), with a specific focus on the subtype predominantly presenting with somatic symptoms. tPBM is a non-invasive neuromodulation technique that utilizes near-infrared light to stimulate the prefrontal cortex. It potentially improves energy metabolism and neural function while offering advantages such as high safety and minimal side effects. Although preliminary studies support its antidepressant potential, evidence regarding the relationship between treatment parameters, stimulation frequencies, and subtype-specific efficacy remains limited.
This prospective, randomized controlled trial expects to enroll 40 TRD subjects, who will be randomly assigned to either a 10 Hz or a 40 Hz group. Both groups will receive tPBM treatment twice a week for four consecutive weeks. Pre- and post-treatment clinical assessments will evaluate depressive symptoms (HDRS-17, MADRS), somatic symptoms (PHQ-15, DSSS), sleep quality, and overall functioning. Additionally, paired-pulse transcranial magnetic stimulation (TMS) will be utilized to record neurophysiological changes, specifically assessing alterations in cortical excitability and inhibition.
This study expects to clarify the differences in efficacy between distinct tPBM frequencies in TRD patients, particularly those with somatic symptom-dominant subtypes. Furthermore, it aims to establish a preliminary link among tPBM treatment parameters, neurophysiological markers, and clinical symptom changes, providing a scientific basis and empirical evidence for future precision neuromodulation therapies.
- Being tested
- transcranial photobiomodulation
- Keywords
- Photobiomodulation, Major Depression Disorder, tPBM
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial photobiomodulationDevice
Participants will receive active transcranial photobiomodulation (tPBM) stimulation at a frequency of 10 Hz. The device delivers near-infrared light targeting the prefrontal cortex. Each treatment session lasts for 20 minutes, administered twice a week for four consecutive weeks (totaling 8 sessions).
| Study group | Role | What they receive |
|---|---|---|
| 10 Hz tPBM | Experimental | Not described Receives: Device: transcranial photobiomodulation |
| 40 Hz tPBM | Experimental | Not described Receives: Device: transcranial photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 17-item Hamilton Depression Rating Scale (HDRS-17) Total Score
The 17-item Hamilton Depression Rating Scale (HDRS-17 or HAM-D) is a clinician-administered tool used to assess depression severity, with scores typically ranging from 0-52.
Typical HDRS-17 Scoring Interpretation:
0-7: Normal or remission (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23: Very severe depression
Measured: Baseline, Week 4 (Post-treatment), and Week 8 (1-month follow-up after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start6 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant Depression (TRD)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either 10 Hz or 40 Hz active tPBM treatment.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543328
- Sponsor's protocol ID
- 2025-08-017A
- Other IDs
- V115B-016
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Efficacy of Prefrontal Transcranial Photobiomodulation (tPBM) in Patients With Treatment-Resistant Major Depressive Disorder: A Subgroup Analysis Focusing on Somatic Symptoms
- ClinicalTrials.gov ID
- NCT07543328
- Acronym / sponsor ID
- 2025-08-017A
- Keywords
- Photobiomodulation, Major Depression Disorder, tPBM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to investigate the potential efficacy of transcranial photobiomodulation (tPBM) as an adjunctive antidepressant treatment in patients with treatment-resistant depression (TRD), with a specific focus on the subtype predominantly presenting with somatic symptoms. tPBM is a non-invasive neuromodulation technique that utilizes near-infrared light to stimulate the prefrontal cortex. It potentially improves energy metabolism and neural function while offering advantages such as high safety and minimal side effects. Although preliminary studies support its antidepressant potential, evidence regarding the relationship between treatment parameters, stimulation frequencies, and subtype-specific efficacy remains limited.
This prospective, randomized controlled trial expects to enroll 40 TRD subjects, who will be randomly assigned to either a 10 Hz or a 40 Hz group. Both groups will receive tPBM treatment twice a week for four consecutive weeks. Pre- and post-treatment clinical assessments will evaluate depressive symptoms (HDRS-17, MADRS), somatic symptoms (PHQ-15, DSSS), sleep quality, and overall functioning. Additionally, paired-pulse transcranial magnetic stimulation (TMS) will be utilized to record neurophysiological changes, specifically assessing alterations in cortical excitability and inhibition.
This study expects to clarify the differences in efficacy between distinct tPBM frequencies in TRD patients, particularly those with somatic symptom-dominant subtypes. Furthermore, it aims to establish a preliminary link among tPBM treatment parameters, neurophysiological markers, and clinical symptom changes, providing a scientific basis and empirical evidence for future precision neuromodulation therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either 10 Hz or 40 Hz active tPBM treatment.
| Arm | Type | Receives |
|---|---|---|
| 10 Hz tPBM | Experimental | Device: transcranial photobiomodulation |
| 40 Hz tPBM | Experimental | Device: transcranial photobiomodulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial photobiomodulationParticipants will receive active transcranial photobiomodulation (tPBM) stimulation at a frequency of 10 Hz. The device delivers near-infrared light targeting the prefrontal cortex. Each treatment session lasts for 20 minutes, administered twice a week for four consecutive weeks (totaling 8 sessions). | Device | 10 Hz tPBM, 40 Hz tPBM |
Primary outcome
Change in the 17-item Hamilton Depression Rating Scale (HDRS-17) Total Score
Time frame: Baseline, Week 4 (Post-treatment), and Week 8 (1-month follow-up after treatment)
The 17-item Hamilton Depression Rating Scale (HDRS-17 or HAM-D) is a clinician-administered tool used to assess depression severity, with scores typically ranging from 0-52. Typical HDRS-17 Scoring Interpretation: 0-7: Normal or remission (no depression) 8-13: Mild depression 14-18: Moderate depression 19-22: Severe depression 23: Very severe depression
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial photobiomodulation in people with Treatment-resistant Depression (TRD) and Major Depression Disorder, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia-Shyun Jeng (+886900015031, jscheng2@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 17-item Hamilton Depression Rating Scale (HDRS-17) Total Score (time frame: Baseline, Week 4 (Post-treatment), and Week 8 (1-month follow-up after treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.