Open Pilot Trial of TES for Depression

The University of New South Wales

Status and phase

Completed

Phase 2

Conditions

Major Depression

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01201148

10231

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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).