EARLY-TMS

Effectiveness of rTMS compared to SSRI as early treatment of depression– study protocol of a randomized controlled trial

01/01/2025 to 31/12/2027

Psychotherapy and antidepressants are the first-line treatment options for major depression (MD) but many patients do not respond to these treatment regimes. Therefore, we need alternative well-tolerated treatment methods.
Repetitive transcranial magnetic stimulation (rTMS) is an established treatment for MD, but only for patients who show a certain degree of treatment resistance to the first-line methods currently available. We need randomised-controlled trials (RCTs) investigating first-line treatment with rTMS in comparison with first-line antidepressant medication to expand the alternatives in first-line treatment of MD.
This two-stage, therapy response-adapted, randomised, multi-centre phase II rater-blind trial will enrol 106 medication-naïve patients suffering from MD.In Stage I, participants receive one of the two treatment options for four weeks: daily bilateral theta burst stimulation (TBS), a patterned and time-saving form of rTMS, or antidepressant medication with selective serotonin reuptake inhibitors (SSRI). Patients will then be allocated to Stage II therapy response-adapted, so that they either receive maintenance treatment or are switched to the other treatment arm.The primary outcome is the comparison between the two study arms with regard to therapy response measured by the Montgomery-Asberg Depression Rating Scale (MADRS) after four weeks at the end of Stage I.