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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02894736