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CompletedNCT01849367Updated Sep 17, 2015

Trial of Bilateral tDCS for Depression

A Phase 1/2 interventional study of Eldith Neuroconn tDCS device in Depression, sponsored by The University of New South Wales. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-09-17.

Sponsored by The University of New South Wales · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be measured during the trial.

02

Conditions studied

  • Depression
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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 4 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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participant meets criteria for a DSM-IV Major Depressive episode.
  2. MADRS score of 20 or more.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  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. Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
  5. Participant 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 participant at risk of seizure or neuronal damage with tDCS.
  7. Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  8. Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
  9. Participants who are not fluent in English will not be included in the trial for safety reasons.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Active tDCS (1)

    Device: Eldith Neuroconn tDCS device

  • Active comparator
    Active tDCS (2)

    Device: Eldith Neuroconn tDCS device

Interventions

  • DeviceEldith Neuroconn tDCS device
06

What researchers measure

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

    Time frame: 4 weeks

07

Study locations

1 site
  • Black Dog Institute / University of New South Wales
    Sydney, New South Wales 2031, Australia
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01849367
Lead sponsor
The University of New South Wales
Responsible party
Colleen Loo (Professor, The University of New South Wales) — Principal investigator
First posted
May 8, 2013
Start date
May 2013
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Sep 17, 2015

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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