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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Trial of Transcranial Direct Current Stimulation (tDCS) for Depression
Scientific title
Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) for Depression.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
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

Study type
Description of intervention(s) / exposure
Treatment: Devices - tDCS (Eldith DC-Stimulator (CE certified))

Experimental: Active tDCS -

Treatment: Devices: tDCS (Eldith DC-Stimulator (CE certified))
Each tDCS session lasting continuously for 20 minutes at 2 mA

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale for Depression (MADRS). - Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment
Timepoint [1] 0 0
6 months

Key inclusion criteria
1. Subject meets criteria for a DSM-IV Major Depressive Episode.

2. Total MADRS score =20.

3. Subject has not responded to tDCS given with a standard montage OR subject is unable
to receive tDCS with standard montage - for example, due to skin rash etc at site of
electrode placement for standard montage.
Minimum age
18 Years
Maximum age
90 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating
disorder (current or within the past year); obsessive compulsive disorder (lifetime);
post-traumatic stress disorder (current or within the past year); mental retardation.

2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the
last 3 months (except nicotine and caffeine).

3. Inadequate response to ECT in the current episode of depression.

4. Subject is on regular benzodiazepine medication which it is not clinically appropriate
to discontinue.

5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide

6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at
risk of seizure or neuronal damage with tDCS.

7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts,
abrasions, rash) at proposed electrode sites.

8. Female subject who is pregnant.

9. Participants who are not fluent in English will not be included in the trial for
safety reasons: a) It is usually not possible to have an interpreter reliably
available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject
who cannot tell us immediately of any side effects; b) As this is a novel treatment,
the study involves detailed neuropsychological testing for safety reasons. This
testing cannot be effectively or validly completed by someone who is not fluent in
English. Note that translation of the proposed tests into English has not been
validated and that we cannot be confident that neuropsychological impairment would be
detected using this method.

Study design
Purpose of the study
Allocation to intervention
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 2
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
The University of New South Wales

Ethics approval
Ethics application status

Brief summary
Among antidepressant treatments, ECT stands as the most effective in treating acute
depression. However, patient concerns with the cognitive side effects of ECT have encouraged
the development of new and more focal forms of brain stimulation such as transcranial Direct
Current Stimulation (tDCS). However, not all patients may respond to this treatment in the
way that it is currently administered and this has raised interest in finding alternative,
possibly more optimal ways of administering tDCS. This study will investigate whether tDCS
stimulation using an alternative electrode montage has antidepressant effects.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Colleen Loo, MBBS, FRANZCP, MD
Address 0 0
School of Psychiatry, University of New South Wales
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
Other publications