NCT04781127

Brief Summary

This study will determine the safety and efficacy of home administered tDCS in adults with unipolar depression. The device used to administer tDCS will be the Soterix Medical 1X1 mini-CT. 32 tDCS sessions of 30 minutes each will be delivered over 10 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2021

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

February 10, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

February 25, 2021

Last Update Submit

January 27, 2023

Conditions

Unipolar DepressionTreatment Resistant Depression

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

  • Change in Mood

    Mood will be assessed with the Montgomery Asberg Depression Rating Scale (MADRS). Patients who meet criteria for clinical response (\>=50% improvement in MADRS) may continue with maintenance treatments of once a week for 2 months and once every 2 weeks for the remaining 3 months.

    Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)

Secondary Outcomes (7)

  • Self-Reported Mood Score

    Weeks 1-10. Patients who receive maintenance sessions will also report before sessions 33-46 (Weeks 11-30)

  • Quick Inventory of Depressive Symptomology (QIDS-SR)

    Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30

  • Quality of Life Enjoyment and Satisfaction Questionnaire Form (Q-LES-Q-SF)

    Weeks 1-10. Patients who receive maintenance sessions will also report at the end of Weeks 11-18, 20, 22, 24, 26, 28, 30

  • Columbia Suicide Severity Rating Scale (C-SSRS)

    Baseline, at the end of Weeks 2, 4 ,6 during the acute phase, at completion of taper phase (end of Week 10) and during the Follow-up period (end of Weeks 18 and 30)

  • Self-report Columbia Suicide Severity Rating Scale (C-SSRS)

    Weeks 1-10

  • +2 more secondary outcomes

Study Arms (1)

Active tDCS

EXPERIMENTAL

Active Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator

Device: Soterix Medical mini-CT tDCS stimulator

Interventions

Soterix Medical mini-CT tDCS stimulatorDEVICE

Stimulation will last 30 minutes per day, 5 days per week, for 5 weeks, then 3 days per week for 1 week and then 1 day per week for 4 weeks.

Also known as: Soterix Medical ElectraRx, Soterix Medical SNAPpad
Active tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview.
  • Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
  • Scored at least 20 on the MADRS at trial entry
  • Patient's antidepressant medication is stable for at least 30 days prior to MADRS screening
  • Female patients are allowed if not pregnant and are using a medically acceptable method of contraception, if of childbearing potential

You may not qualify if:

  • DSM-V-TR psychotic disorder
  • Drug or alcohol abuse or dependence in the preceding 3 months
  • Concurrent benzodiazepine medication
  • High suicide risk
  • History of clinically defined neurological disorder or insult
  • Metal in the cranium or skull defects
  • Subjects with an implanted pump, neurostimulator, cardiac pacemaker or defibrillator
  • Skin lesions on scalp at the proposed electrode sites
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University

New York, New York, 10011, United States

Location

Related Publications (1)

  • Brunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.

    PMID: 28657871BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • Abhishek Datta, PhD

    Soterix Medical Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Label
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 4, 2021

Study Start

February 10, 2021

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)