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

Turku University Hospital (TYKS)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Depression

Treatments: Device: Sooma tDCS; Device: Sham tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02521883

T248/2014

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Device: Sooma tDCS

Active Comparator group

Description:

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

Treatment:

Device: Sooma tDCS

Device: Sham tDCS

Placebo Comparator group

Description:

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

Treatment:

Device: Sham tDCS