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
  Purpose

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.


Condition Intervention Phase
Depression
Device: Transcranial Direct Current Stimulation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.

Further study details as provided by The University of New South Wales:

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

Estimated Enrollment: 20
Study Start Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256438

Contacts
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

Locations
Australia, New South Wales
Black Dog Institute Building, School of Psychiatry, University of NSW Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Melissa Pigot, BSc    02 9382 3720    m.pigot@unsw.edu.au   
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00256438     History of Changes
Other Study ID Numbers: 05125
Study First Received: November 17, 2005
Last Updated: July 6, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
Depression
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014