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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01877447
First Posted: June 13, 2013
Last Update Posted: December 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo
  Purpose
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.

Condition Intervention
MAjor Depressive Disorder Device: Transcranial Direct Current Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Further study details as provided by Andre Brunoni, University of Sao Paulo:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression, 17 items (HAMD17) [ Time Frame: Weeks 0, 3 and 6 ]
    reduction of depressive symptoms as assessed by HAMD17


Secondary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Weeks 0, 3 and 6 ]
    reduction of depressive symptoms as assessed by MADRS

  • Beck Depression Inventory (BDI) [ Time Frame: Weeks 0, 3 and 6 ]
    reduction of depressive symptoms as assessed by BDI

  • Beck Anxiety Inventory (BAI) [ Time Frame: Weeks 0, 3 and 6 ]
    reduction of anxiety symptoms as assessed by BAI

  • Hamilton Anxiety Inventory (HAI) [ Time Frame: Weeks 0, 3 and 6 ]
    reduction of anxiety symptoms as assessed by HAI

  • The Montreal Cognitive Assessment (Moca) [ Time Frame: Weeks 0 and 6 ]
    evaluate cognitive stability as assessed by Moca


Enrollment: 30
Study Start Date: July 2013
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cathodal F4

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
Current Stimulation with cathodal stimulation over right dorsolateral prefrontal cortex. Anodal stimulation over left deltoid region
Other Names:
  • tDCS
  • Brain polarization
  • Brain stimulation
Experimental: Anodal F3

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
Current Stimulation with cathodal stimulation over right dorsolateral prefrontal cortex. Anodal stimulation over left deltoid region
Other Names:
  • tDCS
  • Brain polarization
  • Brain stimulation

Detailed Description:
The present research protocol will evaluate clinical effects of 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. Patients will be clinically evaluated with the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for depression. Symptoms intensity will be rated according to The Hamilton Depression Scale (HAMD -17 items) - main outcome. Patients with scores higher than 16 will be included. Patients with active neurological or severe disorders (such as cancer or auto-imune disorders) will be excluded. The present study is a double-blinded, controlled, randomized trial with 30 patients with depression. The intervention protocol consist in 15 consecutive daily tDCS sessions (skipping the weekend). After meeting eligibility criteria, patients will be randomized (computer generated list) to one of the two intervention groups. We will use a direct current of 2.0 milliamperes (mA) for 30 min. The 35 cm2-rubber electrodes will be wrapped in cotton material, which should be moistened with saline as to reduce impedance. Patients will be clinically assessed at baseline and at end of 6 weeks. Main outcome will be based on HAMD-17 items at a final endpoint of 6-weeks, with secondary outcomes assessing Beck Depression Inventory (21 items) at 6 weeks. Other evaluation scales include Beck Anxiety Inventory, Hamilton Anxiety Scale and Safety and cognitive assessment will be performed with The Montreal Cognitive Assessment, adverse effects scales and clinical evaluation with a trained physician.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01877447


Locations
Brazil
Hospital Universitário - USP
Sao Paulo, Brazil, 05508000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Andre R Brunoni, PhD Center of Clinical Research - Hospital Universitário USP; Sao Paulo; Brazil
  More Information

Publications:

Responsible Party: Andre Brunoni, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01877447     History of Changes
Other Study ID Numbers: aF3_cF4_F32
First Submitted: May 24, 2013
First Posted: June 13, 2013
Last Update Posted: December 16, 2013
Last Verified: December 2013

Keywords provided by Andre Brunoni, University of Sao Paulo:
tDCS
Brain stimulation
depressive disorder

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms