NCT04543123

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4 major-depressive-disorder

Timeline
Completed

Started Nov 2017

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.5 years

First QC Date

August 28, 2020

Last Update Submit

September 8, 2020

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Beck Depression Inventory (BDI)

    Weeks 0, 2, 4, and 6

  • Montgomery-Asberg Depression Rating Scale

    Weeks 0, 2, 4, and 6

  • Beck Anxiety Inventory

    Weeks 0, 2, 4, and 6

Study Arms (2)

sham tDCS treatment group

SHAM COMPARATOR

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

Device: tDCS treatmentDrug: Antidepressant Drug(escitalopram)

active tDCS treatment group

EXPERIMENTAL

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

Device: tDCS treatmentDrug: Antidepressant Drug(escitalopram)

Interventions

tDCS treatmentDEVICE

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).

active tDCS treatment groupsham tDCS treatment group
Antidepressant Drug(escitalopram)DRUG

Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.

active tDCS treatment groupsham tDCS treatment group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 9, 2020

Study Start

November 16, 2017

Primary Completion

May 2, 2019

Study Completion

May 2, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

KR(1)