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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/NCT00256438




Registration number
NCT00256438
Ethics application status
Date submitted
17/11/2005
Date registered
21/11/2005
Date last updated
10/07/2006

Titles & IDs
Public title
Depression and Transcranial Direct Current Stimulation (tDCS)
Scientific title
The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.
Secondary ID [1] 0 0
05125
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Transcranial Direct Current Stimulation

Treatment: Devices: Transcranial Direct Current Stimulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All measures at baseline and after each 5 treatments:
Timepoint [1] 0 0
Primary outcome [2] 0 0
Montgomery& Asberg Depression Rating Scale
Timepoint [2] 0 0
Primary outcome [3] 0 0
Hamilton Psychiatric Rating Scale for Depression
Timepoint [3] 0 0
Primary outcome [4] 0 0
Clinical Global Impression-Severity
Timepoint [4] 0 0
Primary outcome [5] 0 0
Beck Depression Inventory
Timepoint [5] 0 0
Primary outcome [6] 0 0
Patient Global Impression-Severity
Timepoint [6] 0 0
Secondary outcome [1] 0 0
Neuropsychological assessment at baseline and after each 5 treatments:
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Rey Auditory Verbal Learning Task
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Digit span
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Trail Making Test
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Controlled Oral Word Association
Timepoint [5] 0 0

Eligibility
Key inclusion criteria
- DSM-IV Major Depressive Episode of less than or equal to 3 years

- Montgomery-Asberg Depression Rating Scale score of 25 or more

- Aged 18-65

- May or may not be taking antidepressant medication
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Not able to give written informed consent

- Failure to respond to ECT in current or past episodes of depression

- On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be
withdrawn.

- Significant other Axis I psychiatric disorder e.g schizophrenia, bipolar

- In imminent physical or psychological danger and needs a rapid clinical response due
to inanition, psychosis or high suicidality

- Drug or alcohol dependence or abuse currently or in the last 12 months

- History of neurological illness e.g epilepsy; neurosurgical procedure

- Metal in the cranium, pacemaker, cochlear implant, medication or other electronic
device in the body

- Woman of child-bearing age in whom pregnancy cannot be ruled out by B HCG

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?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute Building, School of Psychiatry, University of NSW - Sydney
Recruitment postcode(s) [1] 0 0
2031 - 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 non invasive technique which uses a very
weak current to change excitability in targeted regions of the brain. Early studies suggest
that it has antidepressant properties. This study will test the safety and efficacy of tDCS
as a treatment for depression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00256438
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Perminder P Sachdev, FRANZCP PhD
Address 0 0
University of NSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Colleen K Loo, FRANZCP, MD
Address 0 0
Country 0 0
Phone 0 0
02 9382 3721
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00256438