F32 F33 F31
Conditions
Interventions
Group 1: Accelerated intermittent theta-burst stimulation (aiTBS), 5 sessions per day, 5 days
Group 2: Historic control: standard intermittend theta-burst stimulation (iTBS), 1 session per Day, 4 week
Sponsors
Universitätsklinikum der RWTH Aachen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Adult wmen and women between 18 and 80 years-old with a current nonpsychotic depression (either as part of a major depressive disorder or bipolar disorder) according to ICD-10; at least 20 points on the 17-item Hamilton-scale at baseline; nonresponse to at least one antidepressant; stable psychiatric medication in the last two weeks; sufficient German language skills; written informed consent; in case of legal guardianship also informed consent of the legal guardian
Exclusion criteria
Exclusion criteria: Known seizure disorder (epilepsia) or confounding neurological disease, dementia or cognitive impairment; other somatic disease that interfers with the investigation or has an effect on the investigated parameters; current alcohol or drug abuse Drogen-, Alkohol- oder Schmerzmittelabusus; pregnancy or lactation; electromagnetic or metallic medical devices in or connected to the body (e.g., pacemakers, drug pumps, cochlea implants); metal in the body (e.g., screws due to fractures, shards of metal, metal prostheses, non-MR-compatible vascular clips); previous heart and/or brain surgery; widespread tattoos; previous treatment with TMS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) score change from baseline to immediately after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of responders and remitters in the ‘aiTBS’ arm vs. the ‘iTBS’ arm at the end of treatment; score changes from before to after intervention on scales measuring severity of depression (HRSD-17; BDI-II) as well as suicidal tendency (C-SSRS) | — |
Countries
Germany
Contacts
Public ContactKatrin Sakreida
Uniklinik RWTH Aachen
Outcome results
None listed