Back to resultsTrial of Transcranial Direct Current Stimulation (tDCS) for Depression
Primary Purpose
Major Depression
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
tDCS (Eldith DC-Stimulator (CE certified))
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring depression, direct current stimulation, alternative electrode montage
Eligibility Criteria
Inclusion Criteria:
- Subject meets criteria for a DSM-IV Major Depressive Episode.
- Total MADRS score ≥20.
- 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:
- 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.
- 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 tDCS.
- 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.
- 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.
Sites / Locations
- Black Dog Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active tDCS
Arm Description
Outcomes
Primary Outcome Measures
Montgomery Asberg Depression Rating Scale for Depression (MADRS).
Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT01263275
First Posted
December 7, 2010
Last Updated
September 15, 2015
Sponsor
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT01263275
Brief Title
Trial of Transcranial Direct Current Stimulation (tDCS) for Depression
Official Title
Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) for Depression.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
depression, direct current stimulation, alternative electrode montage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
tDCS (Eldith DC-Stimulator (CE certified))
Other Intervention Name(s)
Eldith DC-Stimulator (CE certified)
Intervention Description
Each tDCS session lasting continuously for 20 minutes at 2 mA
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS).
Description
Baseline (pre-treatment), post 8, post 15 and post 20 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject meets criteria for a DSM-IV Major Depressive Episode.
Total MADRS score ≥20.
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:
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.
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 tDCS.
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, MBBS, FRANZCP, MD
Organizational Affiliation
School of Psychiatry, University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Dog Institute
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.blackdoginstitute.org.au
Description
Black Dog Institute website
Learn more about this trial
Trial of Transcranial Direct Current Stimulation (tDCS) for Depression
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