Trial of Bilateral tDCS for Depression

The University of New South Wales1 site in 1 country4 target enrollmentMay 2013

ConditionsDepression

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Depression
Sponsor: The University of New South Wales
Enrollment: 4
Locations: 1
Primary Endpoint: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Mood, cognitive test performance and biomarkers will be measured during the trial.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of New South Wales

Responsible Party

Principal Investigator

Colleen Loo

Professor

The University of New South Wales

Eligibility Criteria

Inclusion Criteria

•Participant meets criteria for a DSM-IV Major Depressive episode.
•MADRS score of 20 or more.

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.
•Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
•Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
•Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
•Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
•Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
•Participants who are not fluent in English will not be included in the trial for safety reasons.