Trial of Transcranial Direct Current Stimulation (tDCS) for Depression

NCT01263275 | Completed Phase 2

• 1 other identifier: 10368
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression

Keywords

depression; direct current stimulation; alternative electrode montage

Outcome Measures

Primary Outcomes (1)

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

  Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment

  6 months

Study Arms (1)

Active tDCS

EXPERIMENTAL

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

Interventions

tDCS (Eldith DC-Stimulator (CE certified)) DEVICE

Each tDCS session lasting continuously for 20 minutes at 2 mA

Also known as: Eldith DC-Stimulator (CE certified)

Active tDCS

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.
• Subject has not responded to tDCS given with a standard montage OR subject is unable to receive tDCS with standard montage - for example, due to skin rash etc at site of electrode placement for standard montage.

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

Study Sites (1)

Black Dog Institute

Randwick, Sydney, New South Wales, 2031, Australia

Location

Related Links

• Black Dog Institute website

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Colleen Loo, MBBS, FRANZCP, MD

  School of Psychiatry, University of New South Wales

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 20, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

AU (1)