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| Name | Class |
|---|---|
| Tampere University Hospital | OTHER |
| Sooma Oy | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Sooma tDCS | Active Comparator | The active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6. |
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| Device: Sham tDCS | Placebo Comparator | The placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sooma tDCS | Device | 2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode). |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tero Taiminen, MD, docent | Contact | +358-2-3131741 | tero.taiminen@tyks.fi |
| Name | Affiliation | Role |
|---|---|---|
| Tero Taiminen, MD, docent | Turku University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö | Recruiting | Lahti | 15850 | Finland |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Sham tDCS | Device | sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode). |
|
| 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 |
| VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka | Recruiting | Lieto | 21420 | Finland |
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| Turku University Hospital | Recruiting | Turku | 20521 | Finland |
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| Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde | Recruiting | Stockholm | Stockholm County | 10233 | Sweden |
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