Efficacy and Biomarkers of Response of TBS in Treatment Resistant Depression (EMTtfNI)
Resistant Depression, Treatment, Bipolar Depression
About this trial
This is an interventional treatment trial for Resistant Depression, Treatment focused on measuring TMS, iTBS, Depression, Bipolar depression, Antidepressants, Neuroimaging, PET-MRI
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Major Depressive Episode or Depressive phase in Bipolar Disorder DSM-5 criteria.
- Moderate severity (>14 points in HDRS)
- 2 antidepressant failures or failure in enhancing strategies in the case of bipolar depression.
- No changes in treatment 3 week previous to the onset of treatment with TMS.
- Ability to sign informed consent.
Exclusion Criteria:
- Any psychiatric comorbidity in axis I or II.
- Depressive episode with psychotic features.
- Dysthymia.
- Treatment with ECT in current depressive episode.
- Multiresistance (> 6 trials of therapeutic strategies).
- Suicide risk assessed previous to each session.
- Patients who missed 2 TMS sessions in a row
- Neurological comorbidities (epilepsy, Parkinson disease, neurocognitive disorders).
- Contraindications to TMS: pregnancy, metallic cervical or head implants.
Sites / Locations
- Hospital Universitario y Politécnico La FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Group Bilateral
Group Unilateral
Group Placebo
32 patients, bilateral active TBS stimulation, Will receive an intensive-spaced protocol Intermittent TBS in left DLPFC and Continuous TBS in right DLPFC
32 patients, unilateral left DLPFC active TBS stimulation. Will receive an intensive-spaced protocol Intermittent TBS in left DLPFC and Sham Continuous TBS in right DLPFC
32 patients, bilateral sham TBS stimulation. Will receive an intensive-spaced protocol of Sham Intermittent TBS in left DLPFC and Sham Continuous TBS in right DLPFC