TBS Treatment for Treatment-Resistant Depression

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 6, 2022

Primary Completion Date

January 1, 2024

Study Completion Date

April 1, 2024

Conditions
Major Depressive DisorderUnipolar Depression
Interventions
PROCEDURE

Theta Burst Stimulation

3 TBS sessions per day, with an offer of 1200 pulses per session and a 30-minute interval between sessions. This protocol will be applied to patients for 15 days, totaling 45 stimulation sessions. The stimulations will be directed to the left dorsolateral prefrontal cortex (F3 obtained by the Beam method) and will be performed in a Magventure MagPro R30 device.The stimulation will be delivered at 100% of the motor threshold and will last for 6 minutes.

PROCEDURE

Sham Stimulation

The placebo will consist of a sham stimulation activity. A noise generator, which makes the same noise as active stimulation, and a surface electrode placed over the patient's eyebrow, mimicking the tactile sensory effects of TBS. It will also occur three times a day, with a duration of 6 minutes. The interval time between procedures will be of 30 minutes. It will take place for the same 15 weekdays, totalizing 45 sham stimulations.

Trial Locations (1)

05403903

Institute of Psychiatry - University of Sao Paulo, São Paulo

All Listed Sponsors
lead

University of Sao Paulo

OTHER