Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
|Major Depressive Disorder||Device: transcranial direct current stimulation||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation|
- Relapse from depression [ Time Frame: Week 4 ]
Once a month, we will address whether the patient has relapsed.
- 2 consecutive MADRS scores > 12 or
- any MADRS scores > 15 or
- suicidal attempt or
- severe suicidal ideation or
- psychiatric hospitalization
- Relapse from depression [ Time Frame: Week 8 ]Same as above.
- Relapse from depression [ Time Frame: Week 12 ]Same as above.
- Relapse from depression [ Time Frame: Week 16 ]Same as above.
- Relapse from depression [ Time Frame: Week 20 ]Same as above.
- Relapse from depression [ Time Frame: Week 24 ]Same as above.
|Study Start Date:||June 2010|
|Study Completion Date:||March 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: 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.
Device: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149213
|University of Sao Paulo|
|Sao Paulo, SP, Brazil|
|Principal Investigator:||Andre R Brunoni, MD||University of Sao Paulo|