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Clinical Trials/NCT02894736
NCT02894736CompletedNot Applicable

Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression

The University of New South Wales2 sites in 1 country34 target enrollmentStarted: March 2016Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
2
Primary Endpoint
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Active tDCS

Experimental

Soterix tDCS machine is used to administer active stimulation

Intervention: Soterix tDCS machine (Device)

Outcomes

Primary Outcomes

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Colleen Loo

Professor

The University of New South Wales

Study Sites (2)

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