Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

Abstract

Introduction: Treatment-resistant depression (TRD) is a debilitating condition affecting 20-30% of patients with major depressive disorders (MDD). Currently, there is no established standard of care for TRD, and wide variation in the clinical approach for disease management has been documented. Real-world data could help describe TRD clinical features, disease burden, and treatment outcome and identify a potential unmet medical need. Methods: We analyzed the Italian data from a European, prospective, multicentric, observational cohort study of patients fulfilling TRD criteria by the European Medicine Agency, with moderate to severe major depressive episode, and starting a new antidepressant treatment according to routinary clinical practice. They were followed up for minimum 6 months. Treatments received throughout the study period, disease severity, health-related quality of life and functioning were prospectively recorded and analyzed. Results: The Italian subcohort included 124 TRD patients (30.2% of patients of the European cohort; mean age 53.2 [sd = 9.8], women: 82, 66.1%). At enrollement, the mean (SD) duration of MDD was 16 years (sd = 11.1) and the mean duration of the ongoing major depressive episode (MDE) was 97.5 weeks (sd = 143.5); low scores of quality of life and functioning were reported. The most frequently antidepressant classes started at baseline (data available for 98 subjects) were selective serotonin reuptake inhibitors (SSRI, 42 patients [42.9%]) and serotonin-norepinephrine reuptake inhibitors (SNRI, 32 patients [32.7%]). In terms of treatment strategies, 50 patients (51%) started augmentation therapies, 18 (18.4%) combination therapies and 24 (24.5%) monoterapies (6 patients [6%] started a non-antidepressant drug only). Fourteen patients (11.3%) were treated with a psychosocial approach, including psychotherapy. After 6 months of treatment, clinical assessments were collected for 89 patients: 64 (71.9%) showed no response, 9 (10.1%) response without remission and 16 (18.0%) were in remission; non-responder patients showed lower quality of life and higher disability scores than responder patients. Conclusions: In our sample of TRD patients, we documented substantial illness burden, low perceived quality of life and poor outcome, suggesting an unmet treatment need in TRD care in Italy. Registration Number: ClinicalTrials.gov, number: NCT03373253.

Keywords: cohort study; health-related quality of life; major depressive disorder; real-world study; treatment outcome; treatment pattern; treatment resistant depression.

Conflict of interest statement

GP received grant/research support from Angelini; speaker/consultant for Angelini, Janssen, Lundbeck, Neuraxpharm, Sanofi Aventis. GR received speaker/consultant fees for Angelini, Innova Pharma, Janssen, Lundbeck and Otsuka. AV received grant/research support and speaker/consultant fees for Angelini, Boheringer Ingelheim, Innovapharma, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Recordati, Roche, Rovi Pharma, Takeda. JM was employed by Janssen EMEA. MA was employed by Janssen-Cilag SpA. GA was employed by Janssen-Cilag SpA. DD was employed by Janssen-Cilag SpA. 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. This article was based on the original study 54135419DEP4001 sponsored by Janssen EMEA. The funder had the following involvement with the study: study design, data collection and analysis, decision to publish, and preparation of the manuscript. Support for third-party writing assistance for this article, provided by Carlotta Galeone (Statinfo srl), was funded by Janssen-Cilag SpA in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3).

Copyright © 2021 Perugi, Calò, De Filippis, Rosso, Vita, Adami, Ascione, Morrens and Delmonte.

Figures

Figure 1

Prior failed antidepressive treatment and treatment started at baseline. *33 patients (26.6%) were treated with add-on mood stabilizers (16 patients [12.9%] with lithium) at baseline (not documented whether treatment onging at baseline or started at baseline). AD, antidepressants; MAOI, monoamine oxidase inhibitors; SGA, second-generation antipsychotics; SNRI, serotonin-norepinephrine reuptake inhibitors; SSRI, selective serotonin reuptake inhibitors; TCA, Tricyclic antidepressants.

Figure 2

Treatment response* among patients with treatment-resistant depression at 6 months. *Remission: Montgomery-Åsberg Depression Rating Scale (MADRS) score ≤10; response (without remission): ≥50% improvement in the MADRS score, with MADRS>10.