Neuropsychiatric Disease and Treatment, Apr 1, 2019
Schizophrenia is a chronic syndrome involving different clinical dimensions, and causes significa... more 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 secondgeneration 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.
Introduction: Treatment-resistant depression (TRD) is a debilitating condition affecting 20-30% o... more 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 Perugi et al. Treatment Resistant Depression: A Cohort Study 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.
It has been shown that a single pulse-dosing (PD) dose of clomipramine improves depressive sympto... more It has been shown that a single pulse-dosing (PD) dose of clomipramine improves depressive symptoms. However, so far PD and conventional (CONV) application of antidepressants have never been directly compared for an extended period. We performed a double-blind study of PD and CONV application of doxepine (DOX) in depressed patients. After a one-week placebo treatment, nine patients in the PD group received 250 mg of DOX every six days and placebo on the other days until day 39. Ten patients in the CONV group received increasing doses of DOX until day 7 and 250 mg DOX on the other days for 39 days. Three dexamethasone (DEX)-suppressiordCRH-stimulation tests were done: 1) during the initial placebo period, 2) on day 9, and 3) on day 21. In the PD group, Hamilton depression rating scale score (HAMD) differed from baseline only after day 36 (17.1 + 7.0 vs. 22.7 + 2.8, p < 0.03). In the CONV group, however, HAMD scores already improved significantly after 2 days (22.8 4-7.2 vs. 26.5 4-5.7, p < 0.02) and continued to improve until day 39 (7.3 4-5.8). From day 25 to 39, there were significant differences between the HAMD scores of the two groups. In the PD group, the decline of cortisol after dexamethasone pretreatment (POST-DEX) was nonsignificant at both follow-up test occasions (35.9 4-40.7 vs. 24.0 4-20.7 vs. 23.6 4-26.6/zg/ml). In the CONV group a significant drop was observed at the second test (61.8 + 61.9 vs. 10.7-4-4.2 4-19.8 + 19 #g/ml, p < 0.05 resp. n.s.). The area-under-the-curve (AUC) cortisol response after CRH was attenuated in the PD group (5667 5:2910 vs. 1883 4-2178 vs. 2239 4-2583, p < 0.01, resp. p < 0.01) and in the CONV group (5710 4-4734 vs. 1267 4-2053 vs. 445 4-1016, n.s., resp. p < 0.02). We conclude that. compared to PD, CONV application of DOX is clinically superior and that both modes of application have attuenuating effects upon HPA-system activity.
Neuropsychiatric Disease and Treatment, Apr 1, 2019
Schizophrenia is a chronic syndrome involving different clinical dimensions, and causes significa... more 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 secondgeneration 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.
Introduction: Treatment-resistant depression (TRD) is a debilitating condition affecting 20-30% o... more 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 Perugi et al. Treatment Resistant Depression: A Cohort Study 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.
It has been shown that a single pulse-dosing (PD) dose of clomipramine improves depressive sympto... more It has been shown that a single pulse-dosing (PD) dose of clomipramine improves depressive symptoms. However, so far PD and conventional (CONV) application of antidepressants have never been directly compared for an extended period. We performed a double-blind study of PD and CONV application of doxepine (DOX) in depressed patients. After a one-week placebo treatment, nine patients in the PD group received 250 mg of DOX every six days and placebo on the other days until day 39. Ten patients in the CONV group received increasing doses of DOX until day 7 and 250 mg DOX on the other days for 39 days. Three dexamethasone (DEX)-suppressiordCRH-stimulation tests were done: 1) during the initial placebo period, 2) on day 9, and 3) on day 21. In the PD group, Hamilton depression rating scale score (HAMD) differed from baseline only after day 36 (17.1 + 7.0 vs. 22.7 + 2.8, p < 0.03). In the CONV group, however, HAMD scores already improved significantly after 2 days (22.8 4-7.2 vs. 26.5 4-5.7, p < 0.02) and continued to improve until day 39 (7.3 4-5.8). From day 25 to 39, there were significant differences between the HAMD scores of the two groups. In the PD group, the decline of cortisol after dexamethasone pretreatment (POST-DEX) was nonsignificant at both follow-up test occasions (35.9 4-40.7 vs. 24.0 4-20.7 vs. 23.6 4-26.6/zg/ml). In the CONV group a significant drop was observed at the second test (61.8 + 61.9 vs. 10.7-4-4.2 4-19.8 + 19 #g/ml, p < 0.05 resp. n.s.). The area-under-the-curve (AUC) cortisol response after CRH was attenuated in the PD group (5667 5:2910 vs. 1883 4-2178 vs. 2239 4-2583, p < 0.01, resp. p < 0.01) and in the CONV group (5710 4-4734 vs. 1267 4-2053 vs. 445 4-1016, n.s., resp. p < 0.02). We conclude that. compared to PD, CONV application of DOX is clinically superior and that both modes of application have attuenuating effects upon HPA-system activity.
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