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Development of non-invasive neuromodulation treatment for depressive disorder by violet light- double-blind, randomized, crossover study

Development of non-invasive neuromodulation treatment for depressive disorder by violet light - double-blind, randomized, crossover study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210260
Enrollment
70
Registered
2021-08-19
Start date
2021-08-19
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Major depressive disorder Depression

Interventions

Sponsors

Kitahata Ryosuke
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed with major depressive disorder according to DSM-5 diagnostic criteria 2)Patients with mild depression with a MADRS score between 15 and 19 3)Patients who can spend 3 hours wearing research equipment with naked eyes (or contact lenses that meet certain criteria*) 4)Outpatient 5)Men and women aged 20 to 74 at the time of obtaining consent 6)Patients who have written informed consent to participate in this study. * Contact lenses with UV protection and colored contact lenses cannot be used

Exclusion criteria

Exclusion criteria: 1)Patients with cerebral organic diseases (intermediate intracranial organic lesions or neurodegenerative diseases, etc.) 2)Patients with a history of seizures or epilepsy 3)Patients with a psychiatric diagnosis other than depression 4)Patients who are receiving psychotherapy in 1 month prior to the screening 5)Patients who are difficult to participate in this study due to mental instability 6)Patients at high risk of suicide such as suicide intent and attempt 7)Patients with serious or unstable physical illness 8)Patients with severe cataract (nuclear sclerosis grade 3 or higher) 9)Patients who underwent ophthalmic surgery within 6 months before obtaining consent. 10)Patients with retinal abnormalities such as serous retinal detachment and retinal hemorrhage 11)Patients with a history of cancer or patients with serious diseases such as cancer 12)Pregnant or lactating patients 13)Other patients who are judged to be inappropriate by the investigator or the investigator

Design outcomes

Primary

MeasureTime frame
Changes in MADRS for 4 weeks between the beginning and end of use of the device

Secondary

MeasureTime frame
Change in the following items from the beginning of use of the e device - HAM-D17 - QIDS-J - MoCA-J - PSQI - BSS - Resting-state EEG

Contacts

Public ContactYoshihiro Noda

Keio University Hospital

yoshi-tms@keio.jp+81-3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026