Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

December 2, 2011 updated by: Andre Brunoni, University of Sao Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Response
Time Frame: Week 1
Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).
Week 1
Treatment response
Time Frame: Week 2
Response defined as above.
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Andre R Brunoni, MD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Estimate)

December 6, 2011

Last Update Submitted That Met QC Criteria

December 2, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP-HU-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on transcranial direct current stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe