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Home-Administered Trial of Direct Current Stimulation (HAT-DCS)

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Soterix tDCS machine
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Black Dog Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active tDCS

Arm Description

Soterix tDCS machine is used to administer active stimulation

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Secondary Outcome Measures

Full Information

First Posted
September 5, 2016
Last Updated
August 1, 2018
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT02894736
Brief Title
Home-Administered Trial of Direct Current Stimulation
Acronym
HAT-DCS
Official Title
Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Soterix tDCS machine is used to administer active stimulation
Intervention Type
Device
Intervention Name(s)
Soterix tDCS machine
Intervention Description
Soterix tDCS machine - miniCT supervised neuromodulation system
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks Total MADRS score ≥ 20 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Alonzo, BSc(Hons)/BA, PhD
Organizational Affiliation
University of New South Wales / Black Dog Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Dog Institute
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Home-Administered Trial of Direct Current Stimulation

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