Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

NCT ID: NCT01149889

Last Updated: 2011-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

transcranial direct current stimulation

Intervention Type PROCEDURE

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

Interventions

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transcranial direct current stimulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Andre Brunoni

P.I., Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre R Brunoni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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USP-HU-002

Identifier Type: -

Identifier Source: org_study_id