Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149889
• Other study ID #: USP-HU-002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 22, 2010
• Last updated: December 2, 2011
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Procedure:
• transcranial direct current stimulation
Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Response	Response is defined as MADRS <=12 or less than 50% of baseline MADRS (Montgomery Asberg depression rating score).	Week 1	No
Primary	Treatment response	Response defined as above.	Week 2	No