TBS Treatment for Treatment-Resistant Depression (TTT)
Major Depressive Disorder, Unipolar Depression
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Unipolar Depression, Major Depressive Disorder, Transcranial Magnetic Stimulation, Neuromodulation, Theta Burst Stimulation, Accelerated Theta Burst Stimulation, Intermittent Theta Burst Stimulation
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria are: patients with a diagnosis of unipolar major depression confirmed by the MINI interview, between 18 and 59 years of age, with a Hamilton score equal to or greater than 17. In addition, patients must have undergone at least 1 first-line treatment for depression and a maximum of 3 previous unsuccessful treatments.
Exclusion Criteria:
- Exclusion criteria are: other mental disorders (bipolar affective disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, personality disorders, substance use disorder, psychotic disorders), history of suicide attempts or severe suicidal ideation in the last 6 months. In addition, patients who have a history of epilepsy, decompensated medical conditions, metallic implants in the skull or previous experience with transcranial magnetic stimulation will be excluded.
Sites / Locations
- Institute of Psychiatry - University of Sao PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active Group - protocol of Theta Burst Stimulation
Placebo Group - Sham Stimulation
3 sessions of theta burst stimulation, 1200 pulses per session of 6 minutes duration, 30-minute interval between sessions. Stimulation directed to the left dorsolateral pre-frontal cortex. The protocol will be applied for 15 days, totalizing 45 sessions of 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.