Trial of Transcranial Direct Current Stimulation (tDCS) Using Alternative Electrode Montages

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). Our current study of tDCS as a treatment for depression suggests that this technique has antidepressant effects and is safe, painless and well tolerated. However, not all patients may respond to this treatment in the way that it is currently administered and the concern of possible relapse in some patients who respond to tDCS has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether using alternative electrode montages can improve the antidepressant effects of tDCS in people suffering from depression.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Black Dog Institute, University of New South Wales

Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject met inclusion criteria for study HREC 07305 (a sham controlled study of transcranial direct current stimulation (tDCS) as a treatment for depression).
Subject completed study HREC 07305.
Subject either did not reach remission at the end of trial (defined as MADRS score of ≤ 10) or suffered an early relapse (within a month of finishing the trial).

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.
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, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).

Treatment and study plan

tDCS (Eldith DC-Stimulator (CE certified))

Device

tDCS session lasting continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm = 35 cm2 & 10 x 10 cm = 100 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).

Other names: Eldith DC-Stimulator (CE certified)

Primary outcomes

Montgomery Asberg Depression Rating Scale for Depression (MADRS).

Time frame: 6 months

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

Secondary outcomes

Inventory of Depressive Symptomatology (IDS-C).

Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2015
Study completion: 2015
First posted: Nov 30, 2009
Registry last updated: May 24, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed