Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

NCT ID: NCT01149213

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-03-31

Brief Summary

The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse.

Detailed Description

Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for depression treatment. The purpose of the present study is to determine whether tDCS is also an effective strategy for sustaining remission.

We will enroll patients who presented remission using tDCS from our previous study and offer them to tDCS every other week for three months, than once a month for another three months. We will address whether tDCS prevents relapse by assessing depression scores once a month, using a time-to-event analysis.

The importance of the present study is to determine whether tDCS is able to sustain remission during long-term follow-up of depressed patients.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcranial Direct Current 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.

The patient will receive tDCS every other week during the first three months, then once a month during the next three months.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

tDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months.

Interventions

transcranial direct current stimulation

tDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Patients from previous studies (ID:USP-HU-001 and ID:USP-HU-002) who:

• received tDCS and responded.
• received tDCS + sertraline and responded.
• received sertraline or placebo and did not respond, and thereafter received tDCS during the cross-over phase and responded.

Exclusion Criteria

Patients from previous studies who:

• received tDCS and did not respond.
• received tDCS + sertraline and did not respond.
• received sertraline or placebo and responded.
• did not respond during the crossover phase.
• do not wish to participate in the present study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Andre Brunoni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andre R Brunoni, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

USP-HU-003

Identifier Type: -

Identifier Source: org_study_id