transcranial photobiomodulation on major depressive disorder

A Single-centered, Randomized, Double-blind, Prospective, Pilot trial to evaluate the antidepressant effect of transcranial-Photobiomodulation device in Major Depressive Disorder patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011969

Enrollment

Registered

2026-05-13

Start date

2025-03-25

Completion date

Unknown

Last updated

2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The active group will receive laser stimulation using a near-infrared transcranial photobiomodulation device. The control group will use a sham device identical in appearance and oper

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals who meet the DSM-5 diagnostic criteria for major depressive disorder. 2. Individuals with an HDRS-17 score of 12 or higher. 3. Individuals who have been taking antidepressant medication at a stable dose and regimen for at least 3 weeks prior to the screening visit. 4. Individuals who are fluent in Korean and have no impairment in reading, writing, hearing, or comprehension abilities. 5. Individuals who agree to participate throughout the entire duration of the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Individuals diagnosed with schizophrenia or bipolar disorder as defined by the DSM-5. 2. Individuals diagnosed within 6 months prior to screening with alcohol use disorder, substance-related disorder, post-traumatic stress disorder, obsessive-compulsive disorder, anorexia nervosa, or bulimia nervosa as defined by the DSM-5. 3. Individuals diagnosed within 1 year prior to screening with dementia, traumatic brain injury, epilepsy, or stroke requiring treatment. 4. Individuals who have attempted suicide within 3 months prior to screening or who are considered by the investigator to have a suicide risk severe enough to require admission to a psychiatric protective ward. 5. Individuals with intracranial metallic implants, including brain stimulators, neurostimulators, aneurysm clips, or cochlear implants. 6. Individuals with uncontrolled cardiovascular, renal, or hepatic disease. 7. Individuals who participated in another clinical trial within 1 month prior to enrollment in this study. 8. Pregnant or breastfeeding women. 9. Individuals deemed by the investigator to be unsuitable for participation in the clinical trial for any other reason.

Design outcomes

Primary

Measure	Time frame
Montgomery-Asberg Depression Scale;Safety	—

Secondary

Measure	Time frame
Hamilton Depression Rating Scale;Beck Anxiety Inventory	—

Countries

Korea, Republic of

Contacts

Public ContactSang Su Ha

St. Peter's Hospital

sshamd@naver.com+82-2-3866-5929

Outcome results