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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

Tracking Information
First Submitted Date  ICMJE September 5, 2016
First Posted Date  ICMJE September 9, 2016
Last Update Posted Date August 2, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2016)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02894736 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Home-Administered Trial of Direct Current Stimulation
Official Title  ICMJE Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE Device: Soterix tDCS machine
Soterix tDCS machine - miniCT supervised neuromodulation system
Study Arms  ICMJE Experimental: Active tDCS
Soterix tDCS machine is used to administer active stimulation
Intervention: Device: Soterix tDCS machine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2016)
36
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02894736
Other Study ID Numbers  ICMJE HC15010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colleen Loo, The University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Angelo Alonzo, BSc(Hons)/BA, PhD University of New South Wales / Black Dog Institute
PRS Account The University of New South Wales
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP