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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01201148
Other study ID # 10231
Secondary ID
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


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
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