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CompletedNCT01346306Updated Mar 30, 2023

Trial of Transcranial Direct Current Stimulation (tDCS)

An interventional study of Eldith Company - direct current stimulator and Eldith Company - direct current stimulator in Major Depression, sponsored by The University of New South Wales. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-03-30.

Sponsored by The University of New South Wales · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

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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Conditions studied

  • Major Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 24 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

The University of New South Wales is the lead sponsor of 65 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    DCS 1

    Device: Eldith Company - direct current stimulator

  • Experimental
    DCS 2

    Device: Eldith Company - direct current stimulator

Interventions

  • DeviceEldith Company - direct current stimulator

    Direct current stimulation montage 1.

    Also known as: Neuroconn - direct current stimulator

  • DeviceEldith Company - direct current stimulator

    Direct current stimulation montage 2.

    Also known as: Neuroconn - direct current stimulator

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What researchers measure

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS).

    Time frame: 4 weeks

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Study locations

2 sites
  • Black Dog Institute
    Randwick, New South Wales 2031, Australia
  • Singapore General Hospital
    Singapore, 169608, Singapore
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01346306
Lead sponsor
The University of New South Wales
Collaborators
Singapore General Hospital
Responsible party
Colleen Loo (Professor, The University of New South Wales) — Principal investigator
First posted
May 2, 2011
Start date
Apr 2011
Primary completion
Dec 23, 2019
Completion
Dec 23, 2019
Last update
Mar 30, 2023

Study contacts

Colleen Loo, MBBS, FRANZCP, MD
principal investigator · School of Psychiatry, University of New South Wales

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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