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

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ClinicalTrials.gov Identifier: NCT02894736
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

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.

Condition or disease Intervention/treatment Phase
Major Depression Device: Soterix tDCS machine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
Study Start Date : March 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS
Soterix tDCS machine is used to administer active stimulation
Device: Soterix tDCS machine
Soterix tDCS machine - miniCT supervised neuromodulation system




Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894736


Locations
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Australia, New South Wales
Black Dog Institute
Randwick, Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
Investigators
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Principal Investigator: Angelo Alonzo, BSc(Hons)/BA, PhD University of New South Wales / Black Dog Institute

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Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT02894736     History of Changes
Other Study ID Numbers: HC15010
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders