Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01149889
First received: June 22, 2010
Last updated: December 2, 2011
Last verified: December 2011

June 22, 2010
December 2, 2011
June 2010
September 2011   (final data collection date for primary outcome measure)
  • Treatment Response [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).
  • Treatment response [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Response defined as above.
Same as current
Complete list of historical versions of study NCT01149889 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation

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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Procedure: transcranial direct current stimulation
Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively
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.
Intervention: Procedure: transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01149889
USP-HU-002
No
Andre Brunoni, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Andre R Brunoni, MD University of Sao Paulo
University of Sao Paulo
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP