Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

Study Overview
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Brief Summary
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Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.

Official Title
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Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation
* Device: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision [DSM-IV-TR]) Baseline score ≥ 13 on the QIDS-C Stable medication regimen (> 4 weeks) Exclusion Criteria: Psychotic features in the current episode Lifetime history of psychotic disorders and/or bipolar I or II disorders Substance or alcohol abuse/dependence in the past 6 months Lifetime history of a major neurological disease (e.g., Parkinson's, stroke) Uncontrolled medical disease (e.g., cardiovascular, renal) Pregnancy and/or lactation Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br> | Device: Transcranial Direct Current Stimulation<br>* 20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)<br>|
| Sham Comparator: Sham tDCS<br> | Device: Transcranial Direct Current Stimulation<br>* The tDCS stimulator will be turned on for 30 seconds only, after which it will be gradually decreased and then turned off for the remainder of the 20-minute daily sessions for 15 days (Monday to Friday on three consecutive weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C) | Response to treatment is defined as a ≥ 50% reduction in pretreatment symptoms severity at as measured by the mean QIDS-C score. Remission is defined as a QIDS-C score ≤ 5 | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 21-item Hamilton Depression Rating Scale (HAM-D21) | Response to treatment is defined as a ≥ 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score ≤ 8 | week 4 | 
| Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) | Response is defined as a ≥ 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score ≤ 5 | week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depression, Transcranial Direct Current Stimulation, Randomized, Sham-Controlled Trial, tDCS