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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Device: Sooma tDCS

The active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6.

Group Type ACTIVE_COMPARATOR

Sooma tDCS

Intervention Type DEVICE

2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Device: Sham tDCS

The placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6.

Group Type PLACEBO_COMPARATOR

Sham tDCS

Intervention Type DEVICE

sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Interventions

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Sooma tDCS

2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Intervention Type DEVICE

Sham tDCS

sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No