Depression
Conditions
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.
Interventions
DEVICESooma tDCS
2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
DEVICESham tDCS
sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
Sponsors
Tampere University Hospital
Sooma Oy
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Montgomery-Åsberg depression scale (MADRS) | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months | Efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dichotomised response measured with MADRS. | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months | Response to treatment is defined as a ≥ 50% reduction in the MADRS baseline score. |
| 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. | baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months | Remission is defined as a MADRS score ≤ 10. |
Countries
Finland, Sweden
Contacts
Primary ContactTero Taiminen, MD, docent
Outcome results
None listed