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1. The Management of Psychomotor Agitation Associated with Schizophrenia or Bipolar Disorder: A Brief Review.

Author

Pompili M, Ducci G, Galluzzo A, Rosso G, Palumbo C, and De Berardis D

Subjects
Humans, Psychomotor Agitation drug therapy, Psychomotor Agitation etiology, Antipsychotic Agents therapeutic use, Bipolar Disorder drug therapy, Loxapine therapeutic use, Schizophrenia complications, Schizophrenia drug therapy
Abstract

The early and correct assessment of psychomotor agitation (PMA) is essential to ensure prompt intervention by healthcare professionals to improve the patient's condition, protect healthcare staff, and facilitate future management. Proper training for recognizing and managing agitation in all care settings is desirable to improve patient outcomes. The best approach is one that is ethical, non-invasive, and respectful of the patient's dignity. When deemed necessary, pharmacological interventions must be administered rapidly and avoid producing an excessive state of sedation, except in cases of severe and imminent danger to the patient or others. The purpose of this brief review is to raise awareness about best practices for the management of PMA in emergency care situations and consider the role of new pharmacological interventions in patients with agitation associated with bipolar disorder or schizophrenia.

Published
2021
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2. Predictive factors of overall functioning improvement in patients with chronic schizophrenia and schizoaffective disorder treated with paliperidone palmitate and aripiprazole monohydrate.

Author

Girardi P, Del Casale A, Rapinesi C, Kotzalidis GD, Splendori F, Verzura C, Trovini G, Sorice S, Carrus D, Mancinelli I, Comparelli A, De Filippis S, Francomano A, Ballerini A, Marcellusi A, Mennini FS, Ducci G, Sani G, Pompili M, and Brugnoli R

Subjects
Adult, Antipsychotic Agents administration & dosage, Aripiprazole administration & dosage, Delayed-Action Preparations, Female, Humans, Male, Middle Aged, Paliperidone Palmitate administration & dosage, Young Adult, Antipsychotic Agents pharmacology, Aripiprazole pharmacology, Outcome Assessment, Health Care, Paliperidone Palmitate pharmacology, Psychotic Disorders drug therapy, Schizophrenia drug therapy
Abstract

Background: Long-acting injectable (LAI) antipsychotics can improve medication adherence and reduce hospitalisation rates compared with oral treatments. Paliperidone palmitate (PAL) and aripiprazole monohydrate (ARI) LAI treatments were associated with improvements in global functioning in patients with schizophrenia., Objective: The objective of this study was to assess the predictive factors of better overall functioning in patients with chronic schizophrenia and schizoaffective disorder treated with PAL and ARI., Method: Enrolled were 143 (97 males, 46 females, mean age 38.24 years, SD = 12.65) patients with a diagnosis of schizophrenia or schizoaffective disorder, whom we allocated in two groups (PAL and ARI treatments). We assessed global functioning, amount of oral medications, adherence to oral treatment, and number of hospitalisations before LAI introduction and at assessment time point., Results: Longer treatment time with LAIs (p < .001), lower number of oral drugs (p < .001), and hospitalisations (p = .002) before LAI introduction, and shorter duration of illness (p = .038) predicted better Global Assessment of Functioning scores in the whole sample (R 2  = 0.337)., Conclusion: Early administration and longer duration of ARI or PAL treatments could play a significant role in improving global functioning of patients with schizophrenia and schizoaffective disorder. Better improvement in functioning could be achieved with ARI in young individuals with recent illness onset and PAL in patients at risk for recurrent hospitalisations., (Copyright © 2018 John Wiley & Sons, Ltd.)

Published
2018
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3. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia.

Author

Nosè M, Accordini S, Artioli P, Barale F, Barbui C, Beneduce R, Berardi D, Bertolazzi G, Biancosino B, Bisogno A, Bivi R, Bogetto F, Boso M, Bozzani A, Bucolo P, Casale M, Cascone L, Ciammella L, Cicolini A, Cipresso G, Cipriani A, Colombo P, Dal Santo B, De Francesco M, Di Lorenzo G, Di Munzio W, Ducci G, Erlicher A, Esposito E, Ferrannini L, Ferrato F, Ferro A, Fragomeno N, Parise VF, Frova M, Gardellin F, Garzotto N, Giambartolomei A, Giupponi G, Grassi L, Grazian N, Grecu L, Guerrini G, Laddomada F, Lazzarin E, Lintas C, Malchiodi F, Malvini L, Marchiaro L, Marsilio A, Mauri MC, Mautone A, Menchetti M, Migliorini G, Mollica M, Moretti D, Mulè S, Nicholau S, Nosè F, Occhionero G, Pacilli AM, Pecchioli S, Percudani M, Piantato E, Piazza C, Pontarollo F, Pycha R, Quartesan R, Rillosi L, Risso F, Rizzo R, Rocca P, Roma S, Rossattini M, Rossi G, Rossi G, Sala A, Santilli C, Saraò G, Sarnicola A, Sartore F, Scarone S, Sciarma T, Siracusano A, Strizzolo S, Tansella M, Targa G, Tasser A, Tomasi R, Travaglini R, Veronese A, and Ziero S

Subjects
Aripiprazole, Clinical Protocols, Drug Therapy, Combination, Government Regulation, Humans, Italy, Prospective Studies, Research Design legislation & jurisprudence, Treatment Outcome, Antipsychotic Agents therapeutic use, Clozapine therapeutic use, Drug Resistance, Haloperidol therapeutic use, Piperazines therapeutic use, Quinolones therapeutic use, Schizophrenia drug therapy, Schizophrenic Psychology
Abstract

Background: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study., Methods/design: The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome., Discussion: The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia.

Published
2009
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4. Ziprasidone vs clozapine in schizophrenia patients refractory to multiple antipsychotic treatments: the MOZART study

Author

Sacchetti, E., Galluzzo, A., Valsecchi, P., Romeo, F., Gorini, B., Warrington, L., Study Group Regini C, M. O. Z. A. R. T., Aguglia, E, Lang, A, Pascolo, E, Antonini, A, D'Amario, A, Croce, F, Matteucci, M, Bilone, F, Bogetto, Filippo, Rocca, Paola, Cirla, M, Rivoira, E, Castrogiovanni, P, Ciappi, F, Attala, T, Perazzi, A, Corradini, P, Piras, A, Boi, R, Carcangiu, E, Del Zompo, M, Ardau, R, Mulas, S, Ducci, G, Cotugno, A, Accorrà, A, Fazzari, G, Garonna, F, Malara, G, Salvatori, F, Maggini, C, Meduri, M, Di Rosa, A, Cardia, R, Parisi, S, Di Rosa, E, Muscettola, G, Casiello, M, Nardini, M, Di Sciascio, G, Sciota, D, Nivoli, G, Nivoli, A, Lorettu, L, Paladin, C, Petralia, A, Fuda, P, Placidi, G, Rossi, M, Raja, M, Amadori, Siracusano, A, Zanasi, M, and Niolu, C.

Subjects
Male, medicine.medical_treatment, Treatment resistance, Piperazines, law.invention, Randomized controlled trial, law, Adult, Analysis of Variance, Antipsychotic Agents, Body Weight, Clozapine, Disease Progression, Dose-Response Relationship, Drug, Double-Blind Method, Drug Therapy, Combination, Female, Glucose, Humans, Italy, Lipids, Middle Aged, Patient Compliance, Psychiatric Status Rating Scales, Quality of Life, Schizophrenia, Schizophrenic Psychology, Thiazoles, Young, Tolerability, Ziprasidone, Psychiatry and Mental health, Drug Therapy, Combination, Psychology, medicine.drug, medicine.medical_specialty, medicine.drug_class, Young Adult, Dose-Response Relationship, Drug, ziprasidone, Atypical antipsychotic, Internal medicine, medicine, Antipsychotic, Settore MED/25 - Psichiatria, Biological Psychiatry, medicine.disease, Endocrinology, Liver function
Abstract

This 18-week, randomized, flexible-dose, double-blind, double-dummy trial evaluated ziprasidone as an alternative to clozapine in treatment-refractory schizophrenia patients. Patients had a DSM-IV diagnosis of schizophrenia, a history of resistance and/or intolerance to at least three acute cycles with different antipsychotics given at therapeutic doses, PANSS scoreor= 80, and CGI-S scoreor= 4. Patients were randomized to ziprasidone (80-160 mg/day, n = 73) or clozapine (250-600 mg/day, n = 74). On the primary ITT-LOCF analysis, baseline-to-endpoint decreases in PANSS total scores were similar in the ziprasidone (- 25.0 +/- 22.0, 95% CI - 30.2 to - 19.8) and clozapine (- 24.5 +/- 22.5, 95% CI - 29.7 to - 19.2) groups. A progressive and significant reduction from baseline in PANSS total score was observed from day 11 in both study arms. There were also significant improvements on PANSS subscales, CGI-S, CG-I, CDSS, and GAF, without between-drug differences. The two treatment groups had similar rates of early discontinuations due to AEs. AEs were mostly of similar mild-moderate severity in the two groups. There were also no detrimental effects on prolactin, renal and liver function, hematology, and cardiovascular parameters. However, ziprasidone but not clozapine showed a significant reduction of SAS and AIMS scores. Moreover, when compared with clozapine, ziprasidone also had a more favorable metabolic profile, with significant endpoint differences in weight, fasting glucose, total cholesterol, LDL cholesterol, and triglycerides. In conclusion, this trial indicates that both ziprasidone and clozapine, having comparable efficacy coupled with satisfactory general safety and tolerability, may be regarded as valuable options for the short-term treatment of difficult-to-treat schizophrenia patients with a history of multiple resistance and/or intolerance to antipsychotics. The more favorable metabolic profile of ziprasidone may represent an added value that could guide clinicians, at least in the presence of patients at high risk for metabolic disorders.

Published
2009

5. Model of Management (Mo.Ma) for the patient with schizophrenia: Crisis control, maintenance, relapse prevention, and recovery with long-acting injectable antipsychotics (LAIs)

Author

Brugnoli, R., Rapinesi, C., Kotzalidis, G. D., Andrea Marcellusi, Mennini, F. S., Filippis, S., Carrus, D., Ballerini, A., Francomano, A., Ducci, G., Del Casale, A., and Girardi, P.

Subjects
Disease Management, Health Care Costs, LAIs, long-acting injectable antipsychotic drugs, recovery, Models, Theoretical, Medication Adherence, Hospitalization, Early Diagnosis, Double-Blind Method, Recurrence, Risk Factors, Delayed-Action Preparations, Quality of Life, Schizophrenia, Humans, Algorithms, Antipsychotic Agents, Randomized Controlled Trials as Topic
Abstract

Schizophrenia is a severe mental disease that affects approximately 1% of the population with a relevant chronic impact on social and occupational functioning and daily activities. People with schizophrenia are 2-2.5 times more likely to die early than the general population. Non-adherence to antipsychotic medications, both in chronic and first episode schizophrenia, is one of the most important risk factors for relapse and hospitalization, that consequently contributes to increased costs due to psychiatric hospitalization. Atypical long-acting injectable (LAI) antipsychotics can improve treatment adherence and decrease re-hospitalization rates in patients with schizophrenia since its onset. The primary goals in the management of schizophrenia are directed not only at symptom reduction in the short and long term, but also at maintaining physical and mental functioning, improving quality of life, and promoting patient recovery.To propose a scientific evidence-based integrated model that provides an algorithm for recovery of patients with schizophrenia and to investigate the effectiveness and safety of antipsychotics LAI in the treatment, maintenance, relapse prevention, and recovery of schizophrenia.After an accurate literature review we identified, collected and analyzed the crucial points in taking care schizophrenia patients, through which we defined the steps described in the model of management and the choice of the better treatment option. Results. In the management model we propose, the choice of a second generation long acting antipsychotic, could allow from the earliest stages of illness better patient management, especially for young individuals with schizophrenia onset, a better recovery and significant reductions of relapse and health care costs. LAI formulations of antipsychotics are valuable, because they help patients to remain adherent to their medication through regular contact with healthcare professionals and to prevent covert non-adherence.The proposed schizophrenia model of management could allow better patient management and recovery, in which the treatment with LAI formulation is a safe and effective therapeutic option. This new therapeutic approach could change the cost structure of schizophrenia by decreasing costs with efficient economic resource allocation guaranteed from efficient diagnostic and therapeutic pathways.

6. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

Author

Paola Colombo, Luisa Ciammella, Giancarlo Giupponi, Francesco Barale, Luigi Grassi, Giorgio Di Lorenzo, Maria Frova, Michela Nosè, Gualtiero Guerrini, Liliana Cascone, Francesco Pontarollo, Rodolfo Tomasi, Alfredo Bisogno, Francesca Sartore, Guglielmo Occhionero, Claudio Santilli, Andrea Giambartolomei, Tiziana Sciarma, Marco Menchetti, Matteo Rossattini, Giuseppe Saraò, Farida Ferrato, Gabriele Cipresso, Alessandra Marsilio, Simone Accordini, Anna Maria Pacilli, Francesco Laddomada, Marianna Boso, Giuseppe Migliorini, Lara Malvini, Camilla Lintas, Antonio Ferro, Alessia Cicolini, Luciana Rillosi, Annamarie Tasser, Alberto Siracusano, Mauro Percudani, Roberto Quartesan, Nicoletta Fragomeno, Nicola Garzotto, Flavio Nosè, Corrado Barbui, Raffaella Bivi, Antonio Mautone, Rossella Beneduce, Gerardo Bertolazzi, Andrea Cipriani, Eleonora Esposito, Alberto Bozzani, Stylianos Nicholau, Barbara Dal Santo, Antonio Veronese, Gino Targa, Rossana Travaglini, Ermanna Lazzarin, Francesco Gardellin, Luigi Ferrannini, Stefania Roma, Giuseppe Rossi, Giovanni Rossi, Alessandra Sala, Bruno Biancosino, Massimo Carlo Mauri, Simona Ziero, Domenico Berardi, Roger Pycha, Walter Di Munzio, Serena Mulè, Michele De Francesco, Filippo Bogetto, Arcadio Erlicher, Carlo Piazza, Francesco Risso, Stefania Strizzolo, Marcello Casale, Vincenzo Fricchione Parise, Lorella Grecu, Silvio Scarone, Paola Artioli, Giuseppe Ducci, Raffella Rizzo, Michele Tansella, Natalia Grazian, Livio Marchiaro, Daniele Moretti, Marco Mollica, Paola Rocca, Piera Bucolo, Antonio Sarnicola, Stefania Pecchioli, Ennio Piantato, Francesca Malchiodi, Nosè M, Accordini S, Artioli P, Barale F, Barbui C, Beneduce R, Berardi D, Bertolazzi G, Biancosino B, Bisogno A, Bivi R, Bogetto F, Boso M, Bozzani A, Bucolo P, Casale M, Cascone L, Ciammella L, Cicolini A, Cipresso G, Cipriani A, Colombo P, Dal Santo B, De Francesco M, Di Lorenzo G, Di Munzio W, Ducci G, Erlicher A, Esposito E, Ferrannini L, Ferrato F, Ferro A, Fragomeno N, Parise VF, Frova M, Gardellin F, Garzotto N, Giambartolomei A, Giupponi G, Grassi L, Grazian N, Grecu L, Guerrini G, Laddomada F, Lazzarin E, Lintas C, Malchiodi F, Malvini L, Marchiaro L, Marsilio A, Mauri MC, Mautone A, Menchetti M, Migliorini G, Mollica M, Moretti D, Mulè S, Nicholau S, Nosè F, Occhionero G, Pacilli AM, Pecchioli S, Percudani M, Piantato E, Piazza C, Pontarollo F, Pycha R, Quartesan R, Rillosi L, Risso F, Rizzo R, Rocca P, Roma S, Rossattini M, Rossi G, Sala A, Santilli C, Saraò G, Sarnicola A, Sartore F, Scarone S, Sciarma T, Siracusano A, Strizzolo S, Tansella M, Targa G, Tasser A, Tomasi R, Travaglini R, Veronese A, and Ziero S.

Subjects
REFRACTORY SCHIZOPHRENIA, Schizophrenia, treatment-resistance, antipsychotics, medicine.medical_treatment, Aripiprazole, piperazines, Medicine (miscellaneous), Antipsychotic Agents, Clinical Protocols, Clozapine, Drug Therapy, Combination, Government Regulation, Haloperidol, Humans, Italy, Piperazines, Prospective Studies, Quinolones, Research Design, Treatment Outcome, Drug Resistance, Schizophrenic Psychology, law.invention, haloperidol, Study Protocol, DOUBLE-BLIND, Randomized controlled trial, law, Pharmacology (medical), schizophrenic psychology, humans, antipsychotic agents, clinical protocols, clozapine, drug resistance, drug therapy, combination, government regulation, haloperidol, humans, Italy, piperazines, prospective studies, quinolones, research design, schizophrenia, schizophrenic psychology, treatment outcome, lcsh:R5-920, treatment-resistant schizophrenia, aripiprazole, clozapine, ANTIPSYCHOTIC DRUGS, PRAGMATIC TRIALS, CLINICAL TRIALS, AUGMENTATION, METAANALYSIS, government regulation, antipsychotic agents, research design, drug therapy, lcsh:Medicine (General), medicine.drug, medicine.medical_specialty, Context (language use), medicine, clinical protocols, Antipsychotic, Psychiatry, Settore MED/25 - Psichiatria, Polypharmacy, combination, drug resistance, business.industry, medicine.disease, prospective studies, Clinical trial, schizophrenia, treatment outcome, quinolones, business
Abstract

Background One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. Methods/Design The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. Discussion The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia. Trial Registration Clincaltrials.gov Identifier: NCT00395915

Published
2009

7. Economic aspects in the treatment of schizophrenia in Italy: Cost consequences of an early long-acting injectable anti-psychotics (lais) approach.

Author

Marcellusi, A., Mennini, F.S., Brugnoli, R., Rapinesi, C., Kotzalidis, G.D., De Filippis, S., Carrus, D., Ballerini, A., Francomano, A., Ducci, G., Del Casale, A., and Girardi, P.

Subjects
*SCHIZOPHRENIA treatment, *ANTIPSYCHOTIC agents, *HOSPITAL care, *MEDICAL economics
Abstract

Purpose The aim of this analysis was to evaluate the economic consequences of a new treatment approach in the treatment of schizophrenia in the Italian setting. In terms of direct costs, in Italy was estimated that the main driver were represented by hospitalization and residential cost (71% of total direct cost per patient), followed by semi-residential services (13%), anti-psychotic and other drugs (8%) and ambulatory services (8). Methods A probabilistic cost consequence model was developed to estimate the potential cost reductions derived from an early treatment with atypical long-acting injectable anti-psychotics (aLAIs) drugs. A systematic literature review was carried out to identify direct and indirect costs associated to the management of schizophrenic patients in Italy. The model projects a scenario analysis in order to estimate potential cost reductions applying a new model management (MoMa) based on patient recovery and early aLAIs treatment. Results Overall, the total economic burden associated with schizophrenia was estimated at €2.7 billion per year. A total of 50.5% of the economic burden was related to indirect costs and 49.5% to direct costs. Drug costs correspond to 10% of the total expenditure in terms of direct costs, while hospitalization and residential costs accounts for 81%. Scenario analysis demonstrate a potential cost reduction between 200 million and 300 million based on the effects of MoMa over the reduction of hospitalization and residential costs. Conclusions This analysis was the first attempt to translate clinical management aspects in economic consequences and will be a useful instruments for decision maker. [ABSTRACT FROM AUTHOR]

Published
2017
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