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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02894736
Other study ID # HC15010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date July 2018

Study information

Verified date August 2018
Source The University of New South Wales
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Soterix tDCS machine
Soterix tDCS machine - miniCT supervised neuromodulation system

Locations

Country Name City State
Australia Black Dog Institute Randwick, Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montgomery Asberg Depression Rating Scale for Depression (MADRS) 6 months
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