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Trial of Transcranial Direct Current Stimulation (tDCS) Using Alternative Electrode Montages

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01021709
First received: November 27, 2009
Last updated: May 22, 2016
Last verified: May 2016
  Purpose
Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our current study of tDCS as a treatment for depression suggests that this technique has antidepressant effects and is safe, painless and well tolerated. However, not all patients may respond to this treatment in the way that it is currently administered and the concern of possible relapse in some patients who respond to tDCS has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether using alternative electrode montages can improve the antidepressant effects of tDCS in people suffering from depression.

Condition Intervention Phase
Major Depression
Device: tDCS (Eldith DC-Stimulator (CE certified))
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment


Secondary Outcome Measures:
  • Inventory of Depressive Symptomatology (IDS-C). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment


Enrollment: 29
Study Start Date: November 2009
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tDCS with alternative electrode montage
Treating major depression with either alternative tDCS electrode montage.
Device: tDCS (Eldith DC-Stimulator (CE certified))
tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm = 35 cm2 & 10 x 10 cm = 100 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
Other Name: Eldith DC-Stimulator (CE certified)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
  2. Subject completed study HREC 07305.
  3. Subject either did not reach remission at the end of trial (defined as MADRS score of ≤ 10) or suffered an early relapse (within a month of finishing the trial).

Exclusion Criteria:

  1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder current or within the past year); mental retardation.
  2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  3. Inadequate response to ECT in the current episode of depression.
  4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
  7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  8. Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
  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: NCT01021709

Locations
Australia, New South Wales
Black Dog Institute, University of New South Wales
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
  More Information

Additional Information:
Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01021709     History of Changes
Other Study ID Numbers: 09343 
Study First Received: November 27, 2009
Last Updated: May 22, 2016
Health Authority: Australia: University of New South Wales Human Research Ethics Committee
Australia: Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
depression
direct current stimulation
extracephalic electrode

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

ClinicalTrials.gov processed this record on December 02, 2016