Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

Yonsei University

Status: Completed

Conditions: Depression

Treatments: Device: transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05539131

2022-0225-002

Details and patient eligibility

About

Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology.

Full description

As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

Enrollment: 198 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

Exclusion criteria

• Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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198 participants in 2 patient groups

active transcranial direct current stimulation (tDCS)

Active Comparator group

Description:

daily active transcranial direct current stimulation (tDCS) use for 6 weeks

Treatment:

Device: transcranial direct current stimulation (tDCS)

sham transcranial direct current stimulation (tDCS)

Sham Comparator group

Description:

daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks

Treatment:

Device: transcranial direct current stimulation (tDCS)