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Multicentre, retrospective observational cohort study based on LHU administrative databases aimed to described the pharmacoutilization of antipsychotics in patients affected by schizophrenia and bipolar disorder, the resource consumption and medication adherence. A sub analysis will be performed for those patients switching from Quetiapine IR to Quetiapine XR and comparing the periods before and after the switch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment with antipsychotics | 40 LHU covering about 18 millions inhabitants distributed all over Italy with a coverage of nearly 100% of Italian regions. All subjects will be included in the analysis who have received treatment with antipsychotics (typical and / or atypical) between January 1, 2009 and June 30, 2010 and diagnosed with schizophrenia and / or Bipolar Disorder. |
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| Measure | Description | Time Frame |
|---|---|---|
| Describe the pharmacoutilization of antipsychotics treatment (including typical and atypical) for patients affected by schizophrenia and bipolar disorder in order to evaluate the level of treatment variability for these patients | The reference date, the Index Date for patients included in the analysis will be identified on the basis of the date of first prescription of antipsychotics in the period January 1, 2009 - June 30, 2010 or, for those that do not result in treatment with antipsychotics, according to the date of diagnosis of schizophrenia or bipolar disorder, if that date is within the period 1 January 2009 - June 30, 2010, otherwise the date will be January 1, 2009 | Index Data up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the costs of illness of patients with schizophrenia or bipolar disorder | The reference date, the Index Date for patients included in the analysis will be identified on the basis of the date of first prescription of antipsychotics in the period January 1, 2009 - June 30, 2010 or, for those that do not result in treatment with antipsychotics, according to the date of diagnosis of schizophrenia or bipolar disorder, if that date is within the period 1 January 2009 - June 30, 2010, otherwise the date will be January 1, 2009 |
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Inclusion Criteria:
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All patients from 40 LHU
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| Name | Affiliation | Role |
|---|---|---|
| Flore La Tour | AstraZeneca | Study Chair |
| Raffaele Sabia | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Arezzo | AR | Italy | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9519087 | Background | Brown S. Excess mortality of schizophrenia. A meta-analysis. Br J Psychiatry. 1997 Dec;171:502-8. doi: 10.1192/bjp.171.6.502. | |
| 8275890 | Background | Tabbane K, Joober R, Spadone C, Poirier MF, Olie JP. [Mortality and cause of death in schizophrenia. Review of the literature]. Encephale. 1993 Jan-Feb;19(1):23-8. French. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| Index Data up to 18 months |
| To evaluate adherence level for patients treated with antipsychotics | The reference date, the Index Date for patients included in the analysis will be identified on the basis of the date of first prescription of antipsychotics in the period January 1, 2009 - June 30, 2010 or, for those that do not result in treatment with antipsychotics, according to the date of diagnosis of schizophrenia or bipolar disorder, if that date is within the period 1 January 2009 - June 30, 2010, otherwise the date will be January 1, 2009 | Index Data up to 18 months |
| A sub analysis will be performed to evaluate any differences in terms of cost of illness and medication adherence for those patients switching from quetiapine IR to quetiapine XR in order to understand the implications of the different formulations. | The reference date, the Index Date for patients included in the analysis will be identified on the basis of the date of first prescription of antipsychotics in the period January 1, 2009 - June 30, 2010 or, for those that do not result in treatment with antipsychotics, according to the date of diagnosis of schizophrenia or bipolar disorder, if that date is within the period 1 January 2009 - June 30, 2010, otherwise the date will be January 1, 2009 | Index Data up to 18 months |
| Bergamo |
| BG |
| Italy |
| Research Site | Bolzano | BZ | Italy |
| Research Site | Forlì | FC | Italy |
| Research Site | Ferrara | FE | Italy |
| Research Site | Florence | FI | Italy |
| Research Site | Lecce | LE | Italy |
| Research Site | Matera | MT | Italy |
| Research Site | Monza E Brianza | MZ | Italy |
| Research Site | Piacenza | PC | Italy |
| Research Site | Ravenna | RA | Italy |
| Research Site | Ragusa | RG | Italy |
| Research Site | Teramo | TE | Italy |
| Research Site | Milan | Italy |
| Research Site | Molise | Italy |
| Research Site | Rome | Italy |
| 7906710 | Background | Opler LA, Caton CL, Shrout P, Dominguez B, Kass FI. Symptom profiles and homelessness in schizophrenia. J Nerv Ment Dis. 1994 Mar;182(3):174-8. doi: 10.1097/00005053-199403000-00008. |
| 11465308 | Background | Begley CE, Annegers JF, Swann AC, Lewis C, Coan S, Schnapp WB, Bryant-Comstock L. The lifetime cost of bipolar disorder in the US: an estimate for new cases in 1998. Pharmacoeconomics. 2001;19(5 Pt 1):483-95. doi: 10.2165/00019053-200119050-00004. |
| 10182198 | Background | Foster RH, Goa KL. Risperidone. A pharmacoeconomic review of its use in schizophrenia. Pharmacoeconomics. 1998 Jul;14(1):97-133. doi: 10.2165/00019053-199814010-00009. |
| 3083800 | Background | Keller MB, Lavori PW, Klerman GL, Andreasen NC, Endicott J, Coryell W, Fawcett J, Rice JP, Hirschfeld RM. Low levels and lack of predictors of somatotherapy and psychotherapy received by depressed patients. Arch Gen Psychiatry. 1986 May;43(5):458-66. doi: 10.1001/archpsyc.1986.01800050064007. |
| 8911225 | Background | Kendler KS, Gallagher TJ, Abelson JM, Kessler RC. Lifetime prevalence, demographic risk factors, and diagnostic validity of nonaffective psychosis as assessed in a US community sample. The National Comorbidity Survey. Arch Gen Psychiatry. 1996 Nov;53(11):1022-31. doi: 10.1001/archpsyc.1996.01830110060007. |
| 10826667 | Background | Tondo L, Baldessarini RJ. Reduced suicide risk during lithium maintenance treatment. J Clin Psychiatry. 2000;61 Suppl 9:97-104. |
| 2250501 | Background | Kelly GR, Scott JE, Mamon J. Medication compliance and health education among outpatients with chronic mental disorders. Med Care. 1990 Dec;28(12):1181-97. doi: 10.1097/00005650-199012000-00006. |
| 9846389 | Background | Duncan JC, Rogers R. Medication compliance in patients with chronic schizophrenia: implications for the community management of mentally disordered offenders. J Forensic Sci. 1998 Nov;43(6):1133-7. |
| 2889495 | Background | The Scottish First Episode Schizophrenia Study. II. Treatment: pimozide versus flupenthixol. The Scottish Schizophrenia Research Group. Br J Psychiatry. 1987 Mar;150:334-8. doi: 10.1192/bjp.150.3.334. |
| 2873851 | Background | Young JL, Zonana HV, Shepler L. Medication noncompliance in schizophrenia: codification and update. Bull Am Acad Psychiatry Law. 1986;14(2):105-22. |
| 1357703 | Background | Buchanan A. A two-year prospective study of treatment compliance in patients with schizophrenia. Psychol Med. 1992 Aug;22(3):787-97. doi: 10.1017/s0033291700038228. |
| 9585716 | Background | Keck PE Jr, McElroy SL, Strakowski SM, West SA, Sax KW, Hawkins JM, Bourne ML, Haggard P. 12-month outcome of patients with bipolar disorder following hospitalization for a manic or mixed episode. Am J Psychiatry. 1998 May;155(5):646-52. doi: 10.1176/ajp.155.5.646. |
| 16464201 | Background | Catalan VS, LeLorier J. Predictors of long-term persistence on statins in a subsidized clinical population. Value Health. 2000 Nov-Dec;3(6):417-26. doi: 10.1046/j.1524-4733.2000.36006.x. |
| 15292538 | Background | Weiden PJ, Kozma C, Grogg A, Locklear J. Partial compliance and risk of rehospitalization among California Medicaid patients with schizophrenia. Psychiatr Serv. 2004 Aug;55(8):886-91. doi: 10.1176/appi.ps.55.8.886. |
| 25312446 | Derived | Degli Esposti L, Sangiorgi D, Mencacci C, Spina E, Pasina C, Alacqua M, la Tour F. Pharmaco-utilisation and related costs of drugs used to treat schizophrenia and bipolar disorder in Italy: the IBIS study. BMC Psychiatry. 2014 Oct 14;14:282. doi: 10.1186/s12888-014-0282-z. |