Lurasidone in adolescents and adults with schizophrenia: from clinical trials to real-world clinical practice.

INTRODUCTION: Lurasidone is an atypical antipsychotic agent approved in the European Union for the treatment of schizophrenia in adults and adolescents (13-17 years). Clinical trials have shown a generally favorable balance between efficacy and tolerability. AREAS COVERED: This paper provides a review and commentary regarding the use of lurasidone in adults and adolescents with schizophrenia. The available information about efficacy, tolerability, dosing, and switching is analyzed, highlighting the strategies that may be most useful in real-world clinical practice. Virtual case studies, designed based on the authors' clinical experience with real-world patients, are provided. EXPERT OPINION: Lurasidone is efficacious in adolescents and adults in a wide range of symptoms of schizophrenia. Choosing the right dose for each patient and combining lurasidone with other medications is key to treatment success. Lurasidone has proven effective both in adolescents and adults in treating the acute phase of schizophrenia and reducing the risk of relapse. It has shown a relatively favorable tolerability profile, with minimal effects on metabolic parameters and prolactin levels.

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-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.

The modern perspective for long-acting injectables antipsychotics in the patient-centered care of schizophrenia.

Schizophrenia is a chronic syndrome involving different clinical dimensions, and causes significant disability with a negative impact on the quality of life of patients and their caregivers. Current guidelines for the treatment of schizophrenia focus on maximizing a patient's adaptive functioning and quality of life in a recovery-oriented approach that encourages active collaboration among patients, caregivers, and mental health professionals to design and manage a customized and comprehensive care plan. In the present study, a panel of experts (psychiatrists, psychologists, nurse, and social worker) gathered to review and explore the need for contemporary use of second-generation antipsychotic long-acting injectables (SGA LAIs) in "recovery-oriented" and "patient-centered" care of schizophrenia. Starting from the available data and from sharing personal attitudes and experiences, the panel selected three clinical dimensions considered useful in characterizing each patient: phase of disease, adherence to treatment, and level of functioning. For each clinical dimension, perspectives of patients and caregivers with regard to needs, expectations, and personal experiences were reviewed and the role of SGA LAIs in achieving shared goals examined. The experts concluded that from today's modern perspectives, SGA-LAIs may play an important role in breaking the spiral of desocialization and functional decline in schizophrenia, thus favoring the recovery process.