Comparison of Two tDCS Protocols for the Treatment of Major Depressive Disorder

NCT01877447 | Completed DMC

• 1 other identifier: aF3_cF4_F32
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

MAjor Depressive Disorder

Keywords

tDCS; Brain stimulation; depressive disorder

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression, 17 items (HAMD17)

  reduction of depressive symptoms as assessed by HAMD17

  Weeks 0, 3 and 6

Secondary Outcomes (5)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  Weeks 0, 3 and 6

• Beck Depression Inventory (BDI)

  Weeks 0, 3 and 6

• Beck Anxiety Inventory (BAI)

  Weeks 0, 3 and 6

• Hamilton Anxiety Inventory (HAI)

  Weeks 0, 3 and 6

• The Montreal Cognitive Assessment (Moca)

  Weeks 0 and 6

Study Arms (2)

cathodal F4

EXPERIMENTAL

Transcranial Direct Current Stimulation Cathodal tDCS over F4 (right dorsolateral prefrontal cortex) Anodal tDCS over the left deltoid (extra-cephalic) n=15

Device: Transcranial Direct Current Stimulation

Anodal F3

EXPERIMENTAL

Transcranial Direct Current Stimulation' Anodal tDCS over F3 (right dorsolateral prefrontal cortex) Cathodal tDCS over the right deltoid (extra-cephalic) n=15

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Current Stimulation with cathodal stimulation over right dorsolateral prefrontal cortex. Anodal stimulation over left deltoid region

Also known as: tDCS, Brain polarization, Brain stimulation

Anodal F3; cathodal F4

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• active neurologic or severe disorder (such as cancer or auto-imune)
• pregnancy;
• need for hospitalization

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Universitário - USP

São Paulo, São Paulo, 05508000, Brazil

Location

Related Publications (6)

• Brunoni AR, Kemp AH, Shiozawa P, Cordeiro Q, Valiengo LC, Goulart AC, Coprerski B, Lotufo PA, Brunoni D, Perez AB, Fregni F, Bensenor 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.

  PMID: 23615118 BACKGROUND

• Brunoni AR, Benute GR, Fraguas R, Santos NO, Francisco RP, de Lucia MC, Zugaib M. The self-rated Inventory of Depressive Symptomatology for screening prenatal depression. Int J Gynaecol Obstet. 2013 Jun;121(3):243-6. doi: 10.1016/j.ijgo.2013.01.011. Epub 2013 Mar 15.

  PMID: 23499135 BACKGROUND

• 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.

  PMID: 22236735 BACKGROUND

• Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor 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.

  PMID: 23389323 BACKGROUND

• 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.

  PMID: 22651961 BACKGROUND

• 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.

  PMID: 20854868 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Transcranial Direct Current Stimulation; Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Surgical Procedures, Operative

Study Officials

• Andre R Brunoni, PhD

  Center of Clinical Research - Hospital Universitário USP; Sao Paulo; Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 13, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 16, 2013

Record last verified: 2013-12

Locations

BR (1)