Effect of Self-administered tDCS in Patients With MDD

Major Depressive Disorder Clinical Trial

Official title:

Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543123
• Other study ID #: tDCS in MDD
• Status: Completed
• Phase: Phase 4
• Start date: November 16, 2017
• Est. completion date: May 2, 2019

Study information

• Verified date: September 2020
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• tDCS treatment
Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).

Drug:
• Antidepressant Drug(escitalopram)
Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Jeong-Ho Chae	Ybrain Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAM-D)	Hamilton Depression Scale was deployed by a trained psychiatrist at every visit.With a total of 17 questions, the overall score is rated from 0 to 34, and higher total scores indicate more severe depression symptoms	Change from Baseline Hamilton Depression Scale at 6 weeks
Secondary	Beck Depression Inventory (BDI)	The self-rated scale of the Beck Depression Inventory (BDI) was completed by participants. With a total of 21 questions, the score is rated from 0 to 33, and higher total scores indicate more severe depression symptoms.	Weeks 0, 2, 4, and 6
Secondary	Montgomery-Asberg Depression Rating Scale	Montgomery-Asberg Depression Rating Scale was deployed by a trained psychiatrist at every visit. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.	Weeks 0, 2, 4, and 6
Secondary	Beck Anxiety Inventory	Beck Anxiety Inventory was deployed by a trained psychiatrist at every visit. The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. The overall score ranges from 0 to 63.	Weeks 0, 2, 4, and 6