Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)

Study Overview
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Brief Summary
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The aim is to investigate the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) in patients with moderate to severe major depression compared to patients treated with conventional therapy. The tDCS will be used as add-on to conventional therapy. This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.

Conditions
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Depression

Intervention / Treatment
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* Device: Sooma tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfils the ICD-10 diagnostic criteria for moderate or severe major depressive episode (F32), or recurrent major depressive episode (F33) Able to understand the purpose and potential risks of the study Able to sign informed consent Exclusion Criteria: intracranial metal implants or other foreign intracranial metal object history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc. schizophrenia bipolar disorder psychotic disorder substance abuse or dependency contra-indications to tDCS personality disorder that may prevent him/her to commit to the study skin lesion in the area of stimulation planned treatment of current depressive episode with ECT or rTMS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device: Sooma tDCS<br>The active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6. | Device: Sooma tDCS<br>* 2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).<br>|
| Placebo Comparator: Device: Sham tDCS<br>The placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6. | Device: Sham tDCS<br>* sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Montgomery-Åsberg depression scale (MADRS) | Efficacy | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichotomised response measured with MADRS. | Response to treatment is defined as a ≥ 50% reduction in the MADRS baseline score. | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months | 
| Change from baseline in Beck Depression Inventory (BDI) scale. |  | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months | 
| Dichotomised remission measured with MADRS. | Remission is defined as a MADRS score ≤ 10. | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months |