Effect of Self-administered tDCS in Patients With MDD

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: tDCS treatment; Drug: Antidepressant Drug(escitalopram)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham tDCS treatment group; the current rose slowly for 30 seconds, descended for 30 seconds, and then remained at zero for 29 minutes	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.
Experimental: active tDCS treatment group; 2mA of current was delivered during the 30 minutes of treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jeong-Ho Chae
• Collaborators: Ybrain Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): May 2, 2019
• Study Completion (Actual): May 2, 2019

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents, Second-Generation; Citalopram; Antidepressive Agents
• Other Study ID Numbers: tDCS in MDD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No