Back to resultsTranscranial Direct Current Stimulation to Treat Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility 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.
Sites / Locations
- University of Sao Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
active stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
Treatment Response
Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).
Treatment response
Response defined as above.
Secondary Outcome Measures
Full Information
NCT ID
NCT01149889
First Posted
June 22, 2010
Last Updated
December 2, 2011
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01149889
Brief Title
Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Official Title
An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
active stimulation
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively
Primary Outcome Measure Information:
Title
Treatment Response
Description
Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).
Time Frame
Week 1
Title
Treatment response
Description
Response defined as above.
Time Frame
Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre R Brunoni, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
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