Open Pilot Trial of TES for Depression

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201148
• Other study ID #: 10231
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2010
• Last updated: November 30, 2015
• Start date: September 2010
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• tDCS (Eldith DC-Stimulator (CE certified))
For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.

Locations

Country	Name	City	State
Australia	Black Dog Institute	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		6 months	No