NCT02657980

Brief Summary

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

June 22, 2015

Last Update Submit

January 24, 2017

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisordertDCSMDDtranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in depressive symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

    Measured by Montgomery-Ã…sberg Depression Rating Scale (MADRS)

    from baseline to Week 6

Secondary Outcomes (5)

  • Effect of tDCS on Depressive Symptoms as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

    At 6 weeks after treatment.

  • Effect of tDCS on questionnaire results as assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)

    At 6 weeks after treatment

  • Average change in results for 2, 4, 6 weeks after treatment as assessed by the clinician-rated Clinical Global Impression-Severity of Illness Scale (CGISI)

    At 2 weeks, 4 weeks and 6 weeks after treatment

  • Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Depression Inventory-II (K-BDI-II)

    At 2 weeks, 4 weeks and 6 weeks after treatment

  • Average change in results for 2, 4, 6 weeks after treatment as assessed by Korean-Beck Anxiety Depression Inventory (K-BAI)

    At 2 weeks, 4 weeks and 6 weeks after treatment

Study Arms (2)

YBand(YDT-201N)

EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (total of 10 applications)

Device: Yband(YDT-201N)

Sham-Yband(YDT-201N)

SHAM COMPARATOR

sham-tDCS application 5 days a week for 2 weeks (total of 10 applications)

Device: Sham-Yband(YDT-201N)

Interventions

Yband(YDT-201N)DEVICE

transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

YBand(YDT-201N)
Sham-Yband(YDT-201N)DEVICE

transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)

Sham-Yband(YDT-201N)

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

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 sertraline 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 that contain sertraline, mono amine oxidase inhibitor, or pimozide
  • Pregnant or has a positive pregnancy serum test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ybrain

Seoul, South Korea

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Seungwoo Lee

    Ybrain Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

January 18, 2016

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

KR(1)