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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT01149213
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-22
• Study First Posted: 2010-06-23
• Primary Completion: 2011-12
• Status Verified: 2012-03
• Study Completion: 2012-03
• Last Update Submitted: 2012-03-24
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial Direct Current Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Relapse from depression	Week 24	Same as above.

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil