IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Schizophrenia Clinical Trial

— IBIS  

Official title:

IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392482
• Other study ID #: NIS-NIT-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: September 14, 2012
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 751725
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bipolar Disorder
• Schizophrenia

Locations

Country	Name	City	State
Italy	Research Site	Arezzo	AR
Italy	Research Site	Bergamo	BG
Italy	Research Site	Bolzano	BZ
Italy	Research Site	Ferrara	FE
Italy	Research Site	Firenze	FI
Italy	Research Site	Forli	FC
Italy	Research Site	Lecce	LE
Italy	Research Site	Matera	MT
Italy	Research Site	Milano
Italy	Research Site	Molise
Italy	Research Site	Monza e Brianza	MZ
Italy	Research Site	Piacenza	PC
Italy	Research Site	Ragusa	RG
Italy	Research Site	Ravenna	RA
Italy	Research Site	Rome
Italy	Research Site	Teramo	TE

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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. — View Citation

Brown S. Excess mortality of schizophrenia. A meta-analysis. Br J Psychiatry. 1997 Dec;171:502-8. — View Citation

Buchanan A. A two-year prospective study of treatment compliance in patients with schizophrenia. Psychol Med. 1992 Aug;22(3):787-97. — View 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. — View 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. — View Citation

Foster RH, Goa KL. Risperidone. A pharmacoeconomic review of its use in schizophrenia. Pharmacoeconomics. 1998 Jul;14(1):97-133. Review. — View 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. — View 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. — View 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. Erratum in: Med Care 1991 Sep;29(9):889. — View 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. — View 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. — View Citation

Tabbane K, Joober R, Spadone C, Poirier MF, Olié JP. [Mortality and cause of death in schizophrenia. Review of the literature]. Encephale. 1993 Jan-Feb;19(1):23-8. Review. French. — View 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. — View Citation

Tondo L, Baldessarini RJ. Reduced suicide risk during lithium maintenance treatment. J Clin Psychiatry. 2000;61 Suppl 9:97-104. Review. — View 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. — View Citation

Young JL, Zonana HV, Shepler L. Medication noncompliance in schizophrenia: codification and update. Bull Am Acad Psychiatry Law. 1986;14(2):105-22. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Index Data up to 18 months	No
Secondary	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	No
Secondary	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	No