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/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
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* On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be withdrawn.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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
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
Trial website
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

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/NCT00256438