Trial of Transcranial Direct Current Stimulation (tDCS)

NCT01346306 | Completed DMC

• 1 other identifier: HC16360
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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.

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

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

  4 weeks

Study Arms (2)

DCS 1

EXPERIMENTAL

Device: Eldith Company - direct current stimulator

DCS 2

EXPERIMENTAL

Device: Eldith Company - direct current stimulator

Interventions

Eldith Company - direct current stimulator DEVICE

Direct current stimulation montage 1.

Also known as: Neuroconn - direct current stimulator

DCS 1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of New South Wales: lead
• Singapore General Hospital: collaborator

Study Sites (2)

Black Dog Institute

Randwick, New South Wales, 2031, Australia

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Colleen Loo, MBBS, FRANZCP, MD

  School of Psychiatry, University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: May 2, 2011
• Study Start: April 1, 2011
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: March 30, 2023

Record last verified: 2023-03

Locations

AU (1); SG (1)