Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression (TDCS-BD)
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|ClinicalTrials.gov Identifier: NCT02152878|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression, Bipolar||Device: Sham stimulation Device: Active stimulation||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||November 2016|
Active Comparator: Active stimulation
Active stimulation (tDCS) will be used in the dose of 2mA /30 min per day, for 10 days and two extra sessions every other week (total of 12 sessions).
Device: Active stimulation
For active tDCS, we will place the anode and the cathode over the left and right dorsolateral prefrontal cortex areas, respectively (corresponding to F3 and F4 according to the EEG 10-20 system). We will use 5x5 cm electrodes and a 2mA current for 30 minutes per day. This montage is known as "bifrontal" setup and has been previously used in major depression trials
Placebo Comparator: Sham stimulation
For Sham Transcranial Direct Current Stimulation, the device is automatically turned off after 30 seconds of stimulation and remains turned off.
Device: Sham stimulation
For sham tDCS, the device will be turned off after 30 seconds of stimulation.
Other Name: TDCS
- Change in Hamilton Scale for Depression, 17 items [ Time Frame: week 0 (baseline), week 2, week 4 and week 6 (endpoint) ]Continuous measure (score change)
- Change in Montgomery-Asberg Depression Rating Scale [ Time Frame: week 0 (baseline), week 2, week 4 and week 6 (endpoint) ]Continuous measure (score changes)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152878
|São Paulo, Brazil, 05508000|
|Principal Investigator:||Andre R Brunoni, MD, PhD||University of São Paulo|