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Trial of Transcranial Direct Current Stimulation (tDCS)

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ClinicalTrials.gov Identifier: NCT01346306
Recruitment Status : Recruiting
First Posted : May 2, 2011
Last Update Posted : February 3, 2017
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Major Depression Device: Eldith Company - direct current stimulator

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial
Study Start Date : April 2011
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346306

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, New South Wales
Black Dog Institute Recruiting
Randwick, Sydney, New South Wales, Australia, 2031
Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD         
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Herng Nieng Chan       chan.herng.nieng@sgh.com.sg   
Principal Investigator: Herng Nieng Chan         
Sponsors and Collaborators
The University of New South Wales
Singapore General Hospital
Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD School of Psychiatry, University of New South Wales
More Information

Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01346306     History of Changes
Other Study ID Numbers: HC16360
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

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