Depression and Transcranial Direct Current Stimulation (tDCS)

Study Overview
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Brief Summary
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Transcranial direct current stimulation (tDCS)is a non invasive technique which uses a very weak current to change excitability in targeted regions of the brain. Early studies suggest that it has antidepressant properties. This study will test the safety and efficacy of tDCS as a treatment for depression.

Detailed Description
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Transcranial direct current stimulation (tDCS) applies a weak direct current across the scalp that can produce sub-threshold changes in the excitability of targeted cortical regions, in a polarity-specific manner. This technique has been used in humans to alter motor and visual cortex excitability, during stimulation, and for a period after the stimulation has ceased. It has therefore been suggested as a possible treatment for depression (Lippold & Redfearn, 1964; Nitsche, 2002). Studies have been launched recently to examine the effect of tDCS in depressed subjects and a sham-controlled pilot study (in USA, in press) has reported promising antidepressant effects with tDCS. We wish to examine this in an investigation of 20 subjects, and hypothesise that tDCS will have an antidepressant effect and produce no neuropsychological impairment. Subjects will receive anodal DC stimulation or sham stimulation over the left prefrontal cortex in a double-blind, placebo-controlled design over 5 days, and then have daily stimulation up to a maximum of 10 active sessions in total. Outcomes will be formally evaluated by depression rating scales and neuropsychological tests.

Official Title
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The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.

Conditions
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Depression

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV Major Depressive Episode of less than or equal to 3 years Montgomery-Asberg Depression Rating Scale score of 25 or more Aged 18-65 May or may not be taking antidepressant medication Exclusion Criteria: Not able to give written informed consent Failure to respond to ECT in current or past episodes of depression On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be withdrawn. Significant other Axis I psychiatric disorder e.g schizophrenia, bipolar In imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicidality Drug or alcohol dependence or abuse currently or in the last 12 months History of neurological illness e.g epilepsy; neurosurgical procedure Metal in the cranium, pacemaker, cochlear implant, medication or other electronic device in the body Woman of child-bearing age in whom pregnancy cannot be ruled out by B HCG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcranial Direct Current Stimulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All measures at baseline and after each 5 treatments: |  |  | 
| Montgomery& Asberg Depression Rating Scale |  |  | 
| Hamilton Psychiatric Rating Scale for Depression |  |  | 
| Clinical Global Impression-Severity |  |  | 
| Beck Depression Inventory |  |  | 
| Patient Global Impression-Severity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological assessment at baseline and after each 5 treatments: |  |  | 
| Rey Auditory Verbal Learning Task |  |  | 
| Digit span |  |  | 
| Trail Making Test |  |  | 
| Controlled Oral Word Association |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Transcranial Direct Current Stimulation