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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00763230




Registration number
NCT00763230
Ethics application status
Date submitted
26/09/2008
Date registered
30/09/2008
Date last updated
2/05/2011

Titles & IDs
Public title
A Study of Transcranial Direct Current Stimulation (tDCS) to Treat Depression
Scientific title
A Sham-controlled Study of Transcranial Direct Current Stimulation (tDCS) as a Treatment for Depression
Secondary ID [1] 0 0
NHMRC (Australia)
Secondary ID [2] 0 0
07305
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial direct current stimulation

Experimental: active - Full active tDCS treatment

Sham Comparator: sham - Placebo tDCS will be give


Treatment: Devices: Transcranial direct current stimulation
tDCS will be given every weekday. For each session, tDCS will be given continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash as described in the safety section above). For sham stimulation, the current will be left on for another 30s, then gradually reduced to zero over another 30 seconds, so that the initial tingling sensation experienced by subjects will be identical for the two groups. The stimulator will be placed behind the subject's head so any adjustments to the current by the operator are not evident. This sham procedure resulted in successful blinding in our pilot study.
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
Secondary outcome [1] 0 0
Inventory of Depressive Symptomatology (IDS-C)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Quick Inventory of Depressive Symptomatology - Self rated (QIDS-SR)
Timepoint [2] 0 0
Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment

Eligibility
Key inclusion criteria
- Meets criteria for DSM-IV Major Depressive Episode
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosis (as defined by DSM-IV) of: any psychotic disorder except bipolar
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.

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

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

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

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

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

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

- Female subject who is pregnant, or of child-bearing age, sexually active and not using
reliable contraception

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
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
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute, University of New South Wales - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

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

Ethics approval
Ethics application status

Summary
Brief summary
Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a
large burden of disease in the community, often due to inadequate treatment. Thus there is
interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such
as transcranial direct current stimulation (tDCS). Two small studies have been published in
the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions
is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests
the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).

This study will extend previous findings, testing a more definitive tDCS approach (also left
prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which
has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger
sample (N=68), using a placebo-controlled design.

It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham
treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an
episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause
any significant adverse effects or cause decline in neuropsychological functioning in
comparison to a sham control.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00763230
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo
Address 0 0
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00763230