Open Pilot Trial of TES for Depression

Phase 2

Completed

• Conditions: Major Depression
• Interventions: Device: tDCS (Eldith DC-Stimulator (CE certified))

• Registration Number: NCT01201148
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oscillating or intermittent tDCS	tDCS (Eldith DC-Stimulator (CE certified))	-

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale for Depression (MADRS)	6 months

Trial Locations

Locations (1)

Black Dog Institute; 🇦🇺 Sydney, New South Wales, Australia