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
  Purpose

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 Intervention Phase
Major Depressive Disorder
Procedure: transcranial direct current stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: June 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149889

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

No publications provided

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
Study First Received: June 22, 2010
Last Updated: December 2, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 30, 2014