CClinicalTrials.gg
Sign In
CompletedNCT01201148Updated Dec 2, 2015

Open Pilot Trial of TES for Depression

A Phase 2 interventional study of tDCS (Eldith DC-Stimulator (CE certified)) in Major Depression, sponsored by The University of New South Wales. Completed at 1 site in Australia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-02.

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

Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.

02

Conditions studied

  • Major Depression

Keywords

  • depression
  • transcranial direct current stimulation (tDCS)
  • random noise stimulation
  • oscillatory tDCS
  • intermittent tDCS
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 7 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 to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject meets criteria for a DSM-IV Major Depressive episode.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
  • Total MADRS depression score of 20 or more
  • 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 TES.
  • 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. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Oscillating or intermittent tDCS

    Device: tDCS (Eldith DC-Stimulator (CE certified))

Interventions

  • DevicetDCS (Eldith DC-Stimulator (CE certified))

    For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.

06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

07

Study locations

1 site
  • Black Dog Institute
    Sydney, New South Wales 2031, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01201148
Lead sponsor
The University of New South Wales
Responsible party
Colleen Loo (Professor, The University of New South Wales) — Principal investigator
First posted
Sep 14, 2010
Start date
Sep 2010
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Dec 2, 2015

Study contacts

Colleen Loo, MBBS
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 Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Depression→

Other studies from this sponsor

The University of New South Wales

Start the discussion