Depression and Transcranial Direct Current Stimulation (tDCS)

July 6, 2006 updated by: The University of New South Wales

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • Recruiting
        • Black Dog Institute Building, School of Psychiatry, University of NSW
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

July 10, 2006

Last Update Submitted That Met QC Criteria

July 6, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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