Effect of Self-administered tDCS in Patients With MDD

Jeong-Ho Chae

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Device: tDCS treatment; Drug: Antidepressant Drug(escitalopram)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04543123

tDCS in MDD

Details and patient eligibility

About

In this randomized, single-blinded clinical trial, 58 patients with major depressive disorder were assigned to active and sham tDCS stimulation groups in a 1:1 ratio, and treatment responses were evaluated biweekly over six weeks.

Full description

Patients were randomized to receive either real or sham-tDCS as well as anti-depressant drugs. tDCS was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (DLPFC). Patients visited the hospital to get tDCS administrations 5 days a week for 2 weeks. They were evaluated every 2 weeks.

Enrollment: 58 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a diagnosis of a major depressive disorder as confirmed by the SCID-IV and MINI (without psychotic features)
• Greater than 22 points of Montgomery-Asberg Depression Rating Scale
• Aged 19 to 65.
• Has provided informed consent
• Has received Escitalopram as a combined antidepressant during the study period

Exclusion criteria

• Has other mental disorders diagnosed by Axis-I, except major depressive disorder (However, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.)
• History of suicidal attempt in the last 6 months
• Diagnosed with bipolar or psychotic major depressive disorder
• Diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified.
• Has hypersensitivity to Escitalopram ingredients
• A score of 5 or greater for the question #10 in MADRS
• Diagnosed with closed angle glaucoma or has a history of glaucoma.
• History of participation in other clinical trials within 30days.
• A major and/or unstable medical or neurologic illness
• Currently taking substances pimozide
• Pregnant or has a positive pregnancy serum test.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

sham tDCS treatment group

Sham Comparator group

Description:

the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes

Treatment:

Device: tDCS treatment

Drug: Antidepressant Drug(escitalopram)

active tDCS treatment group

Experimental group

Description:

2mA of current was delivered during the 30 minutes of treatment

Treatment:

Device: tDCS treatment

Drug: Antidepressant Drug(escitalopram)