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Completed

NCT Number: NCT01346306

Trial of Transcranial Direct Current Stimulation (tDCS)

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Black Dog Institute, Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eldith Company - direct current stimulator

Device

Direct current stimulation montage 1.

Other names: Neuroconn - direct current stimulator

Primary outcomes

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • Singapore General Hospital

Registry information

Official study title

Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
May 2, 2011
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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