Major depressive disorder Mental and Behavioural Disorders Major depressive disorder
Conditions
Interventions
Participants are randomized 1:1 to receive transcranial magnetic theta burst stimulation with
1. Regular targeting method based on skull metrics, or
2. Individually planned targeting based on function
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 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 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. Patients with safety risks including active suicidality, pregnancy, magnetic metal or leads in the upper body, or history of seizures
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/06/2021: 1. Social and occupational functioning scale (SOFAS) rated by research team psychiatrist before and within 2 weeks after treatment 2. Self-evaluated Patient health questionnaire (PHQ-9) measured before and within 2 weeks after treatment and 6 weeks after treatment 3. Remission defined as MADRS 50 % less than MADRS before treatment (rated by research team psychiatrist) _____ Previous secondary outcome measures: 1. Social and occupational functioning scale (SOFAS) rated by research team psychiatrist before and within one week after treatment 2. Self-evaluated Patient health questionnaire (PHQ-9) measured before and within one week after treatment and six weeks after treatment 3. Remission defined as MADRS 50 % less than MADRS before treatment (rated by research team psychiatrist) | — |
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 03/06/2021: Montgomery Åsberg Depression Rating Scale (MADRS) rated by research team psychiatrist before, and within two weeks after treatment _____ Previous primary outcome measure: Montgomery Åsberg Depression Rating Scale (MADRS) rated by research team psychiatrist before, and within one week after treatment | — |
Countries
Finland
Outcome results
None listed