Major depressive disorder, resistant to at least two antidepressants Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of major depressive disorder (DSM-IV) as the principal diagnosis 2. Patient Health Questionnaire-9 score >14 3. Inability to tolerate antidepressant medication or unresponsiveness to minimum of two trials of more than 60 days with adequate dose of antidepressant 4. No change in antidepressive medication within four weeks prior to treatment
Exclusion criteria
Exclusion criteria: 1. Previous rTMS treatment 2. Borderline personality features exceeding 7 points in McLean Screening Instrument for Borderline Personality Disorder, or other somatic or psychiatric conditions that likely interfere with recovery from depression with TMS (an unstable severe medical illness, substantial neurological illness, chronic pain, psychotic disorder or current psychotic symptoms, substance abuse or dependency within last 3 months, >2 mg lorazepine equivalents benzodiazepine use daily or any anticonvulsant, or lifetime history of non-response to an adequate course—ie, a minimum of eight treatments—of electroconvulsive therapy) 3. Safety risks including active suicidality, pregnancy, magnetic metal or leads in the upper body, or history of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptoms measured using the Beck's Depression Inventory-21 (BDI) at baseline, before 6th, 11th, 16th, and 21th and after 25th treatment visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Depressive symptom reduction measured using a subjective Visual Analogue Scale (VAS) at baseline, before 6th, 11th, 16th, 21th and after 25th treatment visit | — |
Countries
Finland