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

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...

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Autores principales:	Giulio Perugi, Paola Calò, Sergio De Filippis, Gianluca Rosso, Antonio Vita, Marina Adami, Giuseppe Ascione, Joachim Morrens, Dario Delmonte
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	treatment resistant depression treatment outcome health-related quality of life cohort study treatment pattern real-world study Psychiatry RC435-571
Acceso en línea:	https://doaj.org/article/515c7dc8815e4145b496e95bff51f63f
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spelling	oai:doaj.org-article:515c7dc8815e4145b496e95bff51f63f2021-11-05T15:30:47ZClinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study1664-064010.3389/fpsyt.2021.769693https://doaj.org/article/515c7dc8815e4145b496e95bff51f63f2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fpsyt.2021.769693/fullhttps://doaj.org/toc/1664-0640Introduction: 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.Giulio PerugiPaola CalòSergio De FilippisGianluca RossoGianluca RossoAntonio VitaAntonio VitaMarina AdamiGiuseppe AscioneJoachim MorrensDario DelmonteFrontiers Media S.A.articletreatment resistant depressiontreatment outcomehealth-related quality of lifecohort studytreatment patternreal-world studyPsychiatryRC435-571ENFrontiers in Psychiatry, Vol 12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	treatment resistant depression treatment outcome health-related quality of life cohort study treatment pattern real-world study Psychiatry RC435-571
spellingShingle	treatment resistant depression treatment outcome health-related quality of life cohort study treatment pattern real-world study Psychiatry RC435-571 Giulio Perugi Paola Calò Sergio De Filippis Gianluca Rosso Gianluca Rosso Antonio Vita Antonio Vita Marina Adami Giuseppe Ascione Joachim Morrens Dario Delmonte Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study
description	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.
format	article
author	Giulio Perugi Paola Calò Sergio De Filippis Gianluca Rosso Gianluca Rosso Antonio Vita Antonio Vita Marina Adami Giuseppe Ascione Joachim Morrens Dario Delmonte
author_facet	Giulio Perugi Paola Calò Sergio De Filippis Gianluca Rosso Gianluca Rosso Antonio Vita Antonio Vita Marina Adami Giuseppe Ascione Joachim Morrens Dario Delmonte
author_sort	Giulio Perugi
title	Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study
title_short	Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study
title_full	Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study
title_fullStr	Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study
title_full_unstemmed	Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study
title_sort	clinical features and outcomes of 124 italian patients with treatment resistant depression: a real-world, prospective study
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/515c7dc8815e4145b496e95bff51f63f
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Clinical Features and Outcomes of 124 Italian Patients With Treatment Resistant Depression: A Real-World, Prospective Study

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