Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02894736




Registration number
NCT02894736
Ethics application status
Date submitted
5/09/2016
Date registered
9/09/2016
Date last updated
2/08/2018

Titles & IDs
Public title
Home-Administered Trial of Direct Current Stimulation
Scientific title
Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
Secondary ID [1] 0 0
HC15010
Universal Trial Number (UTN)
Trial acronym
HAT-DCS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Soterix tDCS machine

Experimental: Active tDCS - Soterix tDCS machine is used to administer active stimulation


Treatment: Devices: Soterix tDCS machine
Soterix tDCS machine - miniCT supervised neuromodulation system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
* Total MADRS score = 20
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2018
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02894736
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Angelo Alonzo, BSc(Hons)/BA, PhD
Address 0 0
University of New South Wales / Black Dog Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02894736