Assessment of Patients Affected by Treatment-Resistant Depression: Findings from a Real-World Study in Italy

Author(s): Perrone Valentina, Sangiorgi Diego, Andretta Margherita, Ducci Giuseppe, Forti Bruno, Francesa Morel Pier Cesare, Gambera Marco, Maina Giuseppe, Mencacci Claudio, Mennini Francesco, Zanalda Enrico,

The study aims to estimate the number of patients affected by treatment-resistant depression (TRD) in Italy, and to analyse the therapeutic pathways and drug utilization in real-world settings. This retrospective study is based on administrative databases of Italian Entities. Data were re-proportioned on the Italian population. Adult patients were included from July 2011 to December 2017 if they underwent ≥2 antidepressant (AD) cycles matching the following criteria: i) duration of ≥4 weeks for each cycle; ii) presence of ≥1 prescription for each AD at the maximum dosage reported in the datasheet; iii) grace period of ≤ 30 days to switch between AD; iv) if no changing occurs, treatment maintained ≥9 months. Patients prescribed antipsychotics or mood stabilizers in the 6-months prior inclusion were excluded. Sensitivity analyses were performed taking into account ≥6 and ≥8 weeks with the same AD or considering the mean maximum dosage (84.2% of maximum dosage). Considering the Italian population, 101,455 patients were estimated to have TRD according to the inclusion/exclusion criteria applied and represented the 4.2% of patients prescribed AD in Italy. For thresholds of ≥6 and ≥8 weeks for cycle duration, TRD patients were estimated to be 97,223 and 96,213, respectively. When the mean maximum dosage criterion was selected, 130,049 TRD patients were identified: of them, 45,198 had ?a psychiatric visit/hospitalization, 32,341 of which added another AD/mood-stabilizer/antipsychotic to the current therapy. In conclusion, we gave an estimation at the National level of TRD patients in Italy, considering different AD dosages and AD cycle durations to provide realistic scenarios.

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