NCT02894736

Brief Summary

Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

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

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

September 5, 2016

Last Update Submit

August 1, 2018

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    6 months

Study Arms (1)

Active tDCS

EXPERIMENTAL

Soterix tDCS machine is used to administer active stimulation

Device: Soterix tDCS machine

Interventions

Soterix tDCS machineDEVICE

Soterix tDCS machine - miniCT supervised neuromodulation system

Active tDCS

Eligibility Criteria

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

You may qualify if:

  • Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
  • Total MADRS score ≥ 20

You may not qualify if:

  • Diagnosis of any DSM-IV psychotic disorder
  • History of drug or alcohol abuse or dependence in the preceding 3 months
  • High suicide risk
  • Clinically defined neurological disorder or insult
  • Metal in the cranium or skull defects
  • Skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Dog Institute

Randwick, Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Angelo Alonzo, BSc(Hons)/BA, PhD

    University of New South Wales / Black Dog Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2016

First Posted

September 9, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

August 2, 2018

Record last verified: 2018-08

Locations

AU(1)