Trial of Transcranial Direct Current Stimulation (tDCS) for Depression

Study Overview
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Brief Summary
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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.

Official Title
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Open Pilot Trial of Transcranial Direct Current Stimulation (tDCS) for Depression.

Conditions
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Major Depression

Intervention / Treatment
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* Device: tDCS (Eldith DC-Stimulator (CE certified))


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br> | Device: tDCS (Eldith DC-Stimulator (CE certified))<br>* Each tDCS session lasting continuously for 20 minutes at 2 mA<br>* Other names: Eldith DC-Stimulator (CE certified);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, direct current stimulation, alternative electrode montage