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

Completed

• Conditions: Major depressive disorder

• Registration Number: jRCTs032210260

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-19
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional
• Study Design: crossover assignment

Primary Outcome Measures

Name	Time	Method
-		Changes in MADRS for 4 weeks between the beginning and end of use of the device

Secondary Outcome Measures

Name	Time	Method
HAM-D17		Change in HAM-D17 from the beginning of use of the device
QIDS-J		Change in QIDS-J from the beginning of use of the device
MoCA-J		Change in MoCA-J from the beginning of use of the device
PSQI		Change in PSQI from the beginning of use of the device
BSS		Change in BSS from the beginning of use of the device
Resting-state EEG		Change in Resting-state EEG from the beginning of use of the device