The Scania Accelerated Intermittent Theta-burst Implementation Study (SATIS)-Lessons from an accelerated treatment protocol.

Background And Objective: The Scania Accelerated Intermittent Theta-burst Implementation Study (SATIS) aimed to investigate the tolerability, preliminary effectiveness, and practical feasibility of an accelerated intermittent theta burst stimulation (aTBS) protocol in treating depression.

Methods: We used an open-label observational design, recruiting 20 patients (aged 19-84 years) from two public brain stimulation centers in Sweden. During the five-day treatment period and at a follow-up visit after 30 days we closely monitored adverse events and collected self-rated side effect data. Objective (MADRS, CGI) and subjective (MADRS-S) measures of symptoms and functioning (EQ-5D) were also assessed. Feasibility was evaluated using direct patient ratings combined with a qualitative approach evaluating staff experience.

Results: All patients reported adverse events at some point, the most common being headache (18/20 patients), but they were generally transient. MADRS scores decreased from 28.4 (min = 17, max = 38. SD = 6.9) at baseline to 20.0 (min = 1, max = 42. SD = 11.6) after the last day of treatment. 25% (n = 5) met the response criteria, with a mean time to response of 2.2 days (min = 1, max = 3. SD = 1.1). The practical arrangements surrounding this new treatment proved challenging for the organization, but patients reported few practical problems.

Conclusion: SATIS provided further insights into the potential benefits and challenges associated with aTBS protocols. Effectiveness and drop-out rates were comparable to national data of conventional iTBS, but with a markedly faster time to response. More resources were required than anticipated, increasing the clinical workload.