Depression and Transcranial Direct Current Stimulation (tDCS)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2006 by The University of New South Wales.
Recruitment status was Recruiting

Sponsor:

Information provided by:

The University of New South Wales

ClinicalTrials.gov Identifier:

NCT00256438

First received: November 17, 2005

Last updated: July 6, 2006

Last verified: July 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2005

Last Updated Date

July 6, 2006

Start Date ^ICMJE

February 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

All measures at baseline and after each 5 treatments:
Montgomery& Asberg Depression Rating Scale
Hamilton Psychiatric Rating Scale for Depression
Clinical Global Impression-Severity
Beck Depression Inventory
Patient Global Impression-Severity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00256438 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Neuropsychological assessment at baseline and after each 5 treatments:
Rey Auditory Verbal Learning Task
Digit span
Trail Making Test
Controlled Oral Word Association

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Depression and Transcranial Direct Current Stimulation (tDCS)

Official Title ^ICMJE

The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.

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.

Detailed Description

Transcranial direct current stimulation (tDCS) applies a weak direct current across the scalp that can produce sub-threshold changes in the excitability of targeted cortical regions, in a polarity-specific manner. This technique has been used in humans to alter motor and visual cortex excitability, during stimulation, and for a period after the stimulation has ceased. It has therefore been suggested as a possible treatment for depression (Lippold & Redfearn, 1964; Nitsche, 2002). Studies have been launched recently to examine the effect of tDCS in depressed subjects and a sham-controlled pilot study (in USA, in press) has reported promising antidepressant effects with tDCS.

We wish to examine this in an investigation of 20 subjects, and hypothesise that tDCS will have an antidepressant effect and produce no neuropsychological impairment. Subjects will receive anodal DC stimulation or sham stimulation over the left prefrontal cortex in a double-blind, placebo-controlled design over 5 days, and then have daily stimulation up to a maximum of 10 active sessions in total. Outcomes will be formally evaluated by depression rating scales and neuropsychological tests.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Device: Transcranial Direct Current Stimulation

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Colleen K Loo, FRANZCP, MD	02 9382 3721	colleen.loo@unsw.edu.au
Contact: Perminder P Sachdev, FRANZCP PhD	02 9382 3763	p.sachdev@unsw.edu.au

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00256438

Other Study ID Numbers ^ICMJE

05125

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

The University of New South Wales

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Perminder P Sachdev, FRANZCP PhD	University of NSW
Principal Investigator:	Colleen K Loo, FRANZCP, MD	University of NSW

Information Provided By

The University of New South Wales

Verification Date

July 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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