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Depression and Transcranial Direct Current Stimulation (tDCS)

Primary Purpose

Depression

Status
Unknown status
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Transcranial Direct Current Stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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in current or past episodes of depression On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be withdrawn.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

Sites / Locations

  • Black Dog Institute Building, School of Psychiatry, University of NSWRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2005
Last Updated
July 6, 2006
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT00256438
Brief Title
Depression and Transcranial Direct Current Stimulation (tDCS)
Official Title
The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The University of New South Wales

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Primary Outcome Measure Information:
Title
All measures at baseline and after each 5 treatments:
Title
Montgomery& Asberg Depression Rating Scale
Title
Hamilton Psychiatric Rating Scale for Depression
Title
Clinical Global Impression-Severity
Title
Beck Depression Inventory
Title
Patient Global Impression-Severity
Secondary Outcome Measure Information:
Title
Neuropsychological assessment at baseline and after each 5 treatments:
Title
Rey Auditory Verbal Learning Task
Title
Digit span
Title
Trail Making Test
Title
Controlled Oral Word Association

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen K Loo, FRANZCP, MD
Phone
02 9382 3721
Email
colleen.loo@unsw.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Perminder P Sachdev, FRANZCP PhD
Phone
02 9382 3763
Email
p.sachdev@unsw.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perminder P Sachdev, FRANZCP PhD
Organizational Affiliation
University of NSW
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Colleen K Loo, FRANZCP, MD
Organizational Affiliation
University of NSW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Dog Institute Building, School of Psychiatry, University of NSW
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Pigot, BSc
Phone
02 9382 3720
Email
m.pigot@unsw.edu.au

12. IPD Sharing Statement

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Depression and Transcranial Direct Current Stimulation (tDCS)

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