Major depressive disorder, resistant to at least two antidepressants Mental and Behavioural Disorders
Conditions
Interventions
Participants are randomized 1:1 to receive transcranial magnetic theta burst stimulation with:
1. Regular theta burst protocol
2. New protocol including individually planned targeting
Each group is
Sponsors
Hospital District of Helsinki and Uusimaa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of major depressive disorder (DSM-IV) as the principal diagnosis with Patient Health Questionnaire-9 score >14 2. Inability to tolerate antidepressant medication or unresponsiveness to minimum of 2 months trial with adequate dose of antidepressant 3. No change in antidepressive medication in 4 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 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 - i.e., a minimum of eight treatments - of electroconvulsive therapy) 3. Patients with safety risks including active suicidality, pregnancy, magnetic metal or leads in the upper body, or history of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of depression measured using the Montgomery Åsberg Depression Rating Scale (MADRS) rated before and within 2 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functioning measured using the Social and Occupational Functioning Scale (SOFAS) before and within 2 weeks after treatment 2. Severity of depression measured using the self-evaluated Patient health questionnaire (PHQ-9) before and within 2 weeks after treatment and 6 weeks after treatment 3. Remission defined as MADRS 50 % less than MADRS before treatment | — |
Countries
Finland
Contacts
Public ContactTuukka Raij
Outcome results
None listed