Treatment-resistant depression Mental and Behavioural Disorders
Conditions
Interventions
This is a single-center, observational, within-subject study designed to evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on treatment-resistant depression (TRD). The study
Sponsors
Azienda Ospedaliero-Universitaria Cagliari
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years 2. DSM-5 MDD diagnosis with treatment resistance (TRD) (=2 failed antidepressants) 3. Available for full rTMS treatment and assessments 4. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. Psychiatric comorbidities (bipolar, schizophrenia, active substance use disorder) 2. Neurological conditions (epilepsy, stroke, TBI, neurodegenerative diseases) 3. Metal implants (pacemaker, neurostimulator, cochlear implants) 4. Severe cognitive impairment (low MMSE score) 5. Pregnancy/lactation 6. Recent medication changes (<4 weeks) 7. Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms measured using the Hamilton Depression Rating Scale (HAM-D) at baseline and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline and 4 weeks: 1. Serum BDNF levels measured using a Human-BDNF ELISA kit 2. Cognitive performance measured using a series of cognitive tests: Mini-Mental State Examination (MMSE), Trail-Making Test (TMT), Digit Span Test (DST), and Verbal Fluency Test | — |
Countries
Italy
Contacts
Public ContactEnrico Ginelli
Outcome results
None listed