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

Turku University Hospital4 sites in 2 countries120 target enrollmentMarch 2015

ConditionsDepression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Depression
Sponsor: Turku University Hospital
Enrollment: 120
Locations: 4
Primary Endpoint: Change from baseline in Montgomery-Åsberg depression scale (MADRS)
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

March 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Turku University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in Montgomery-Åsberg depression scale (MADRS)

Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

Efficacy

Secondary Outcomes

Change from baseline in Beck Depression Inventory (BDI) scale.(baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months)
Dichotomised response measured with MADRS.(baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months)
Dichotomised remission measured with MADRS.(baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months)