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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

Kitahata Ryosuke

Shinjuku-Yoyogi mental lab clinic

27-5 Linksquare 3F, Sendagaya 5chome, Shibuya-ku, Tokyo

ryosuke.kitahata.y@gmail.com

Noda Yoshihiro

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-3353-1211

yoshi-tms@keio.jp

Complete

Aug. 19, 2021

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

treatment purpose

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

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

Both

Major depressive disorder

Wearing violet light irradiation goggles

Depression

Photobiomodulation

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

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

+81-3-3470-3360

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