Trial of Transcranial Direct Current Stimulation (tDCS) for Depression
This study is currently recruiting participants.
Verified February 2013 by The University of New South Wales
Sponsor:
The University of New South Wales
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01263275
First received: December 7, 2010
Last updated: February 3, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
Device: tDCS (Eldith DC-Stimulator (CE certified)) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) for Depression. |
Resource links provided by NLM:
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2010 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active tDCS |
Device: tDCS (Eldith DC-Stimulator (CE certified))
Each tDCS session lasting continuously for 20 minutes at 2 mA
Other Name: Eldith DC-Stimulator (CE certified)
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263275
Contacts
| Contact: Angelo Alonzo, PhD | 61-2-93823720 | a.alonzo@unsw.edu.au |
| Contact: Donel Martin, PhD | 61-2-93829261 | donel.martin@unsw.edu.au |
Locations
| Australia, New South Wales | |
| Black Dog Institute | Recruiting |
| Randwick, Sydney, New South Wales, Australia, 2031 | |
| Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au | |
| Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au | |
| Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD | |
Sponsors and Collaborators
The University of New South Wales
Investigators
| Principal Investigator: | Colleen Loo, MBBS, FRANZCP, MD | School of Psychiatry, University of New South Wales |
More Information
Additional Information:
No publications provided
| Responsible Party: | Colleen Loo, Professor, The University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT01263275 History of Changes |
| Other Study ID Numbers: | 10368 |
| Study First Received: | December 7, 2010 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee |
Keywords provided by The University of New South Wales:
|
depression direct current stimulation alternative electrode montage |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013