Trial of Transcranial Direct Current Stimulation (tDCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of New South Wales
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01346306
First received: April 13, 2011
Last updated: May 30, 2014
Last verified: May 2014
  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). However, not all patients may respond to this treatment in the way that it is currently administered and this has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether tDCS stimulation using an alternative electrode montage has antidepressant effects. Further sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood, cognitive test performance and biomarkers will be measured periodically in the duration of the trial.


Condition Intervention Phase
Major Depression
Device: Eldith Company - direct current stimulator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial

Resource links provided by NLM:


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: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2011
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DCS 1 Device: Eldith Company - direct current stimulator
Direct current stimulation montage 1.
Other Name: Neuroconn - direct current stimulator
Experimental: DCS 2 Device: Eldith Company - direct current stimulator
Direct current stimulation montage 2.
Other Name: Neuroconn - direct current stimulator
Sham Comparator: Sham DCS Device: Eldith Company - direct current stimulator
Sham direct current stimulation.
Other Name: Neuroconn - direct current stimulator

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject meets criteria for a DSM-IV Major Depressive Episode.
  • Total MADRS score ≥20.

Exclusion Criteria:

  • Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
  • History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  • Inadequate response to ECT in the current episode of depression.
  • Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  • Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  • Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
  • Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Female subject who is pregnant.
  • Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; b) As this is a novel treatment, the study involves detailed neuropsychological testing for safety reasons. This testing cannot be effectively or validly completed by someone who is not fluent in English. Note that translation of the proposed tests into English has not been validated and that we cannot be confident that neuropsychological impairment would be detected using this method.
  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: NCT01346306

Contacts
Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au
Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au

Locations
Australia, New South Wales
Black Dog Institute Recruiting
Randwick, Sydney, New South Wales, Australia, 2031
Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD         
Sponsors and Collaborators
The University of New South Wales
Investigators
Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD School of Psychiatry, University of New South Wales
  More Information

No publications provided

Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01346306     History of Changes
Other Study ID Numbers: 11036
Study First Received: April 13, 2011
Last Updated: May 30, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on July 24, 2014