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Trial of Transcranial Direct Current Stimulation (tDCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by The University of New South Wales
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01346306
First received: April 13, 2011
Last updated: September 30, 2014
Last verified: September 2014

April 13, 2011
September 30, 2014
April 2011
April 2015   (final data collection date for primary outcome measure)
Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01346306 on ClinicalTrials.gov Archive Site
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Trial of Transcranial Direct Current Stimulation (tDCS)
Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial

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.

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Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Major Depression
  • Device: Eldith Company - direct current stimulator
    Direct current stimulation montage 1.
    Other Name: Neuroconn - direct current stimulator
  • Device: Eldith Company - direct current stimulator
    Direct current stimulation montage 2.
    Other Name: Neuroconn - direct current stimulator
  • Experimental: DCS 1
    Intervention: Device: Eldith Company - direct current stimulator
  • Experimental: DCS 2
    Intervention: Device: Eldith Company - direct current stimulator
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au
Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au
Australia,   Singapore
 
NCT01346306
11036
Yes
Colleen Loo, The University of New South Wales
The University of New South Wales
Singapore General Hospital
Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD School of Psychiatry, University of New South Wales
The University of New South Wales
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP