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Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01149889
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : December 6, 2011
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo

Brief Summary:
The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS) in patients of the investigators previous study who received either placebo or sertraline and have not responded.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Procedure: transcranial direct current stimulation Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation
Study Start Date : June 2010
Primary Completion Date : September 2011
Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: active stimulation
In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
Procedure: transcranial direct current stimulation
Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively

Primary Outcome Measures :
  1. Treatment Response [ Time Frame: Week 1 ]
    Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).

  2. Treatment response [ Time Frame: Week 2 ]
    Response defined as above.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

Patients from a previous study (ID:USP-HU-001) who:

  • received sertraline and did not respond.
  • received placebo and did not respond.

Exclusion criteria:

Patients from a previous study who:

  • received active tDCS.
  • responded.

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): NCT01149889

University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Principal Investigator: Andre R Brunoni, MD University of Sao Paulo

Responsible Party: Andre Brunoni, P.I., Research Associate, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01149889     History of Changes
Other Study ID Numbers: USP-HU-002
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

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