TBS-D

Behandlung der Depression mit bilateraler Theta Burst Stimulation

01/02/2020 to 30/06/2025

Depression is one of the most frequent and devastating psychiatric diseases. The tolerability and efficacy of standard pharmacological and psychotherapeutic treatment is often not sufficient. Repetitive transcranial magnetic stimulation (rTMS) has been put forward as a new treatment option. However, its effectiveness and clinical practicability is still under debate. Theta burst stimulation (TBS) is an advanced and substantially briefer form of rTMS. Non-inferiority of unilateral TBS compared to rTMS has been recently demonstrated in a large controlled study but the required confirmative evidence for the efficacy compared to placebo (sham) stimulation is still missing. We therefore propose a multicenter, double-blind, randomized, sham-controlled, clinical trial testing bilateral TBS as an augmentative treatment of depression to provide reliable confirmative evidence for its clinical efficacy. Totally, 236 patients will be randomized to either active or sham stimula-tion. Treatment will be applied as add-on therapy for 6 weeks with sequentially bilateral TBS (intermitted TBS to the left, continuous TBS to the right dorsolateral prefrontal cortex) each working day. With focus on the relevance for patient care, primary endpoint will be the difference in treatment response-rates of Montgom-ery-Asberg Depression Scale (MADRS ≤ 50% of baseline value) between TBS and PLC. Change of depres-sive symptomatology measured with MADRS, Hamilton Depression Rating Scale (HDRS17), and Inventory of Depressive Symptomatology (IDS-SR) will be secondary endpoints. Sustainability will be assessed by 1 and 3 months follow-up measures.