Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)
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|ClinicalTrials.gov Identifier: NCT02521883|
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : September 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: Sooma tDCS Device: Sham tDCS||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Active Comparator: 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.
Device: Sooma tDCS
2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
Placebo Comparator: 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.
Device: Sham tDCS
sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
- 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
- Dichotomised response measured with MADRS. [ Time Frame: 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. [ Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months ]
- Dichotomised remission measured with MADRS. [ Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months ]Remission is defined as a MADRS score ≤ 10.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521883
|Contact: Tero Taiminen, MD, email@example.com|
|PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö||Recruiting|
|Lahti, Finland, 15850|
|Contact: Mikko Pänkäläinen, MD +358-3-8192952 firstname.lastname@example.org|
|VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka||Recruiting|
|Lieto, Finland, 21420|
|Contact: Alexander Denissoff, MD +358-2-3145970 email@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20521|
|Contact: Tero Taiminen, MD, docent +358-2-3131741 firstname.lastname@example.org|
|Principal Investigator: Tero Taiminen, MD, docent|
|Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde||Recruiting|
|Stockholm, Stockholms Län, Sweden, 10233|
|Contact: Johan Lundberg, MD +46 72 560 84 67 email@example.com|
|Principal Investigator:||Tero Taiminen, MD, docent||Turku University Hospital|