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Completed

NCT Number: NCT02894736

Home-Administered Trial of Direct Current Stimulation

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.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Black Dog Institute

Randwick, Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Soterix tDCS machine

Device

Soterix tDCS machine - miniCT supervised neuromodulation system

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Official study title

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

Acronym: HAT-DCS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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