A Study of Transcranial Electrical Stimulation (TES) for the Treatment of Depression

The University of New South Wales1 site in 1 country7 target enrollmentSeptember 2010

ConditionsMajor Depression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Major Depression
Sponsor: The University of New South Wales
Enrollment: 7
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

This study will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

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

•Subject meets criteria for a DSM-IV Major Depressive episode.

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.
•Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
•Total MADRS depression score of 20 or more
•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 TES.
•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. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).