Routine treatment pathways in a cohort of patients with major depression and suicidality in Italy: the ARIANNA observational study.

Background: Major Depressive Disorder (MDD) with suicidal ideation, intent, or behavior is a psychiatric emergency with controversial care management. Our study describes the comprehensive treatment pathways of this population in Italian routine clinical practice.
Methods: ARIANNA [NCT04463108] is an observational prospective and retrospective cohort study involving both primary data collection and secondary data extract. A total of 137 adult MDD patients with suicidality were enrolled from 24 Italian care sites and followed for 90 days. Other than the description of treatment patterns, the impact of treatment on depressive symptoms and suicidality, the burden on the patient's and caregiver's quality of life, healthcare resource utilization and costs were described.
Results: Of the 133 eligible patients, 68.4% were female, and the median age was 47. Approximately half of the study population had a current severe major depressive episode. Treatment strategies at the time of active suicidal ideation with intent definition/confirmation (t0) were heterogeneous, increasing in complexity during observation. According to the MADRS, patients with remission at t0+1 day were 2.6%, with the mean total score decreasing from 37.2 at t0 to 32.3.
Limitations: The study sites were not randomly selected.
Conclusions: To the best of our knowledge, this is the first cohort study that prospectively describes the characteristics of patients with MDD and suicide risk in Italy, and how they are treated in clinical practice. The study confirms this is a difficult-to-treat population. In addition, a lack of rapid, effective treatment for reducing depressive symptoms and suicidality is observed.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: M. Pompili took part in advisory boards and educational activities on intranasal esketamine, receiving occasional fees for consultations or lectures by Janssen, which are unrelated to this article. In the last 2 years, he has received lectures or advisory board honoraria or engaged in clinical trial activities with Angelini, Lundbeck, Janssen, Pfizer, MSD, and Recordati. B.M. Dell'Osso received lecture honoraria from Angelini, Lundbeck, Janssen, Pfizer, Neuraxpharm, Arcapharma, and Livanova. G. Rosso received speaker/consultant fees for Angelini, Innova Pharma, Janssen, Lundbeck and Otsuka. D. Delmonte was employed by Janssen-Cilag SpA. M. Adami was employed by Janssen-Cilag SpA. G. Ascione was employed by Janssen-Cilag SpA. C. Sansone was employed by Janssen-Cilag SpA. L. Simoni was employed by Medineos SURL (IQVIA Ltd.). R. Cipelli was employed by IQVIA solutions SRL. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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