MAjor Depressive Disorder Clinical Trial
Official title:
Comparison of Two Transcranial Direct Current Stimulation (tDCS) Protocols for the Treatment of Major Depressive Disorder: a Randomized, Double-blinded, Controlled Clinical Trial.
Verified date | December 2013 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ethics Committee |
Study type | Interventional |
Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application of a weak electrical current over the scalp through two electrodes - the anode, which facilitates neuronal depolarization, and the cathode, which leads to neuronal hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically, tDCS displays depression improvement through anodal stimulation over the left dorsolateral prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive during the acute depressive episode. The present study is aimed at comparing two different tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with cathode placed over an extra cephalic area; (2) active cathode placed over the right dorsolateral prefrontal cortex with anode placed over an extra cephalic area.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: - patients with age between 18-89 years, depression diagnosis according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-iV); HAMD scores higher than 16; accordance to inform consent Exclusion Criteria: - active neurologic or severe disorder (such as cancer or auto-imune) - pregnancy; - need for hospitalization |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Universitário - USP | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
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Brunoni AR, Ferrucci R, Bortolomasi M, Vergari M, Tadini L, Boggio PS, Giacopuzzi M, Barbieri S, Priori A. Transcranial direct current stimulation (tDCS) in unipolar vs. bipolar depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):96-101. doi: 10.1016/j.pnpbp.2010.09.010. Epub 2010 Sep 18. — View Citation
Brunoni AR, Ferrucci R, Fregni F, Boggio PS, Priori A. Transcranial direct current stimulation for the treatment of major depressive disorder: a summary of preclinical, clinical and translational findings. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Oct 1;39(1):9-16. doi: 10.1016/j.pnpbp.2012.05.016. Epub 2012 May 28. Review. — View Citation
Brunoni AR, Kemp AH, Shiozawa P, Cordeiro Q, Valiengo LC, Goulart AC, Coprerski B, Lotufo PA, Brunoni D, Perez AB, Fregni F, Benseñor IM. Impact of 5-HTTLPR and BDNF polymorphisms on response to sertraline versus transcranial direct current stimulation: implications for the serotonergic system. Eur Neuropsychopharmacol. 2013 Nov;23(11):1530-40. doi: 10.1016/j.euroneuro.2013.03.009. Epub 2013 Apr 21. — View Citation
Brunoni AR, Valiengo L, Baccaro A, Zanão TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Benseñor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32. — View Citation
Kalu UG, Sexton CE, Loo CK, Ebmeier KP. Transcranial direct current stimulation in the treatment of major depression: a meta-analysis. Psychol Med. 2012 Sep;42(9):1791-800. doi: 10.1017/S0033291711003059. Epub 2012 Jan 12. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Rating Scale for Depression, 17 items (HAMD17) | reduction of depressive symptoms as assessed by HAMD17 | Weeks 0, 3 and 6 | No |
Secondary | Montgomery-Asberg Depression Rating Scale (MADRS) | reduction of depressive symptoms as assessed by MADRS | Weeks 0, 3 and 6 | No |
Secondary | Beck Depression Inventory (BDI) | reduction of depressive symptoms as assessed by BDI | Weeks 0, 3 and 6 | No |
Secondary | Beck Anxiety Inventory (BAI) | reduction of anxiety symptoms as assessed by BAI | Weeks 0, 3 and 6 | No |
Secondary | Hamilton Anxiety Inventory (HAI) | reduction of anxiety symptoms as assessed by HAI | Weeks 0, 3 and 6 | No |
Secondary | The Montreal Cognitive Assessment (Moca) | evaluate cognitive stability as assessed by Moca | Weeks 0 and 6 | Yes |
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