Trial of Transcranial Direct Current Stimulation (tDCS) for Depression

NCT ID: NCT01263275

Last Updated: 2015-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-07-31

Brief Summary

Among antidepressant treatments, ECT stands as the most effective in treating acute depression. However, patient concerns with the cognitive side effects of ECT have encouraged the development of new and more focal forms of brain stimulation such as transcranial Direct Current Stimulation (tDCS). However, not all patients may respond to this treatment in the way that it is currently administered and this has raised interest in finding alternative, possibly more optimal ways of administering tDCS. This study will investigate whether tDCS stimulation using an alternative electrode montage has antidepressant effects.

Conditions

Major Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active tDCS

Group Type: EXPERIMENTAL

tDCS (Eldith DC-Stimulator (CE certified))

Intervention Type: DEVICE

Each tDCS session lasting continuously for 20 minutes at 2 mA

Interventions

tDCS (Eldith DC-Stimulator (CE certified))

Each tDCS session lasting continuously for 20 minutes at 2 mA

Intervention Type: DEVICE

Other Intervention Names

Eldith DC-Stimulator (CE certified)

Eligibility Criteria

Inclusion Criteria

1. Subject meets criteria for a DSM-IV Major Depressive Episode.

2. Total MADRS score ≥20.

3. Subject has not responded to tDCS given with a standard montage OR subject is unable to receive tDCS with standard montage - for example, due to skin rash etc at site of electrode placement for standard montage.

Exclusion Criteria

1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.

2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).

3. Inadequate response to ECT in the current episode of depression.

4. Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.

5. Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.

6. Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.

7. Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.

8. Female subject who is pregnant.

9. Participants who are not fluent in English will not be included in the trial for safety reasons: a) It is usually not possible to have an interpreter reliably available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject who cannot tell us immediately of any side effects; b) As this is a novel treatment, the study involves detailed neuropsychological testing for safety reasons. This testing cannot be effectively or validly completed by someone who is not fluent in English. Note that translation of the proposed tests into English has not been validated and that we cannot be confident that neuropsychological impairment would be detected using this method.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Colleen Loo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen Loo, MBBS, FRANZCP, MD

Role: PRINCIPAL_INVESTIGATOR

School of Psychiatry, University of New South Wales

Locations

Black Dog Institute

Randwick, Sydney, New South Wales, Australia

Countries

Australia

Related Links

http://www.blackdoginstitute.org.au

Black Dog Institute website

Other Identifiers

10368

Identifier Type: -

Identifier Source: org_study_id