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The aim of this study is observation, in an Italian real-world setting, of metabolic effects in patients with schizophrenia who will switch from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or to one of the other four most used atypical antipsychotics.
The aim of this study is the observation, in psychiatric Italian real-world settings, of metabolic effects, effectiveness, side effects and therapeutic adherence in patients with schizophrenia who switched, for any reason (efficacy, safety, metabolic problems, therapeutic adherence or patient's request), from any mono-therapy or poly-therapy antipsychotic regimen to monotherapy with lurasidone or with one of the four most used atypical antipsychotics in Italy (aripiprazole, olanzapine, quetiapine, risperidone). Patient's past medical and psychiatric history of the last 12 months will be also evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COHORT A: Lurasidone | Patients treated with Lurasidone |
| |
| COHORT B: aripiprazole, olanzapine, quetiapine or risperidone) | Patients treated with other atipical antypsicothic as aripiprazole, olanzapine, quetiapine or risperidone) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lurasidone | Drug | Patients are treated with dosages according clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the metabolic parameters | Change in metabolic syndrome in 3 of 5 parameters:
| 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retrospective investigation of the metabolic effects of switches to any atypical antipsychotic occurred in the previous 12 months | Change in metabolic syndrome in 3 of 5 parameters:
|
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult patients (aged > 18 years) affected by schizophrenia according to DSM-5 (Appendix A).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti SOD di Clinica Psichiatrica | Ancona | AN | 60126 | Italy | ||
| Spedali Civili di Brescia Dipartimento di Salute Mentale 1 |
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| aripiprazole, olanzapine, quetiapine or risperidone | Drug | Patients are treated with dosages according clinical practice |
|
| 12 months before baseline (switch to any atypical antipsychotics) |
| Brescia |
| BS |
| 25123 |
| Italy |
| A.O.U. di Cagliari Corso Vittorio Emanuele II, 6 09124 Cagliari (CA) | Cagliari | CA | 09124 | Italy |
| P.O. Gaspare Rodolico - U.O.C. di Psichiatria | Catania | CT | 95125 | Italy |
| AO Mater Domini U.O. Psichiatria | Catanzaro | CZ | 88100 | Italy |
| A.O.U. Ospedali Riuniti di Foggia - S.P.D.C. Viale Pinto 71121 Foggia (FO) | Foggia | FG | 71121 | Italy |
| IRCCS Ospedale Policlinico San Martino | Genova | GE | 16132 | Italy |
| DSM Dipartimento Salute Mentale | Lecce | LE | 73100 | Italy |
| Ospedale S. Gerardo Università Bicocca Dipartimento di Salute Mentale | Monza | MB | 209900 | Italy |
| Ospedale Maggiore Policlinico di Milano U.O. C. di Psichiatria | Milan | MI | 20122 | Italy |
| Ospedale San Raffaele U.O.C. Psichiatria Generale e Riabilitazione | Milan | MI | 20127 | Italy |
| Ospedale Luigi Sacco, S.C. Psichiatria 2 | Milan | MI | 20157 | Italy |
| III S.P.D.C. Azienda Ospedaliera di Padova 35128 Padova - (PD) | Padova | PD | 35128 | Italy |
| Clinica Von Sibenthal Via della Madonnina, 1 | Genzano di Roma | RM | 00045 | Italy |
| Azienda Ospedaliero Universitaria Sant'Andrea | Roma | RM | 00189 | Italy |
| A.O.U. San Luigi Gonzaga - S.C.D.U. di Psichiatria Regione Gonzole, 10 | Orbassano | TO | 10043 | Italy |
| Azienda Ospedaliera Universitaria Federico II - U.O. Psichiatria | Naples | 80131 | Italy |
| Azienda Ospedaliera - Universitaria Senese | Siena | 53100 | Italy |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069056 | Lurasidone Hydrochloride |
| D000068180 | Aripiprazole |
| D000077152 | Olanzapine |
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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