Home-Administered Trial of Direct Current Stimulation

Major Depression Clinical Trial

— HAT-DCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894736
• Other study ID #: HC15010
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

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