Clinical trial NCT01392482: IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder
Official title: IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Keywords: Schizophrenia
Bipolar Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 751725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from 40 LHU

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Schizophrenia or BD (appendix for ICD9-10 codes) or an antipsychotic prescription during the period 1/1/2009-30/06/2010
* patients must be assisted in the LHU for the year before the enrollment ( period 1/1/2009-30/06/2010) until 31/12/2010 or death date if earlier

Primary outcomes:
measure: 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
timeFrame: Index Data up to 18 months
Secondary outcomes:
measure: Describe the costs of illness of patients with schizophrenia or bipolar disorder
timeFrame: Index Data up to 18 months
measure: To evaluate adherence level for patients treated with antipsychotics
timeFrame: Index Data up to 18 months
measure: 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.
timeFrame: Index Data up to 18 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Research Site
state: AR
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Bolzano
country: Italy
facility: Research Site
state: BZ
city: Forli
country: Italy
facility: Research Site
state: FC
city: Ferrara
country: Italy
facility: Research Site
state: FE
city: Firenze
country: Italy
facility: Research Site
state: FI
city: Lecce
country: Italy
facility: Research Site
state: LE
city: Matera
country: Italy
facility: Research Site
state: MT
city: Monza e Brianza
country: Italy
facility: Research Site
state: MZ
city: Piacenza
country: Italy
facility: Research Site
state: PC
city: Ravenna
country: Italy
facility: Research Site
state: RA
city: Ragusa
country: Italy
facility: Research Site
state: RG
city: Teramo
country: Italy
facility: Research Site
state: TE
city: Milano
country: Italy
facility: Research Site
city: Molise
country: Italy
facility: Research Site
city: Rome
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Flore La Tour
role: STUDY_CHAIR
affiliation: AstraZeneca
name: Raffaele Sabia
role: STUDY_DIRECTOR
References:
citation: Brown S. Excess mortality of schizophrenia. A meta-analysis. Br J Psychiatry. 1997 Dec;171:502-8. doi: 10.1192/bjp.171.6.502.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Tondo L, Baldessarini RJ. Reduced suicide risk during lithium maintenance treatment. J Clin Psychiatry. 2000;61 Suppl 9:97-104.
citation: 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.
citation: 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.
citation: 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.
citation: Young JL, Zonana HV, Shepler L. Medication noncompliance in schizophrenia: codification and update. Bull Am Acad Psychiatry Law. 1986;14(2):105-22.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.