Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression (PROTECT)
Depression
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria: adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31) moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 >16 points) response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment <11 points) no concomitant psychotic symptoms. no other relevant psychiatric disorder as assessed by the study physician residence in Germany and German speaking that allows understanding of the information provided patient is capable of giving consent Exclusion Criteria: fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps). severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history) current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates acute suicidality pregnancy current participation in another study
Sites / Locations
- Department of Psychiatry and Psychotherapy, University of RegensburgRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
active treatment
active treatment 2
600 pulses of iTBS per day with 120% resting motor threshold applied five days in one week; tapering interval over 8 months (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)
600 pulses of iTBS per day with 120% resting motor threshold applied five sessions in one day (three treatments with breaks of three weeks; two treatments with breaks of five weeks; one last treatment after eight weeks)