IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder - Full Text View

Purpose

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.

Condition
Schizophrenia Bipolar Disorder

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Schizophrenia

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 [ Time Frame: Index Data up to 18 months ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Describe the costs of illness of patients with schizophrenia or bipolar disorder [ Time Frame: Index Data up to 18 months ] [ Designated as safety issue: No ]
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
To evaluate adherence level for patients treated with antipsychotics [ Time Frame: Index Data up to 18 months ] [ Designated as safety issue: No ]
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
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. [ Time Frame: Index Data up to 18 months ] [ Designated as safety issue: No ]
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

Enrollment:	751725
Study Start Date:	July 2011
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients from 40 LHU

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392482

Locations

Italy
Research Site
Arezzo, AR, Italy
Research Site
Bergamo, BG, Italy
Research Site
Bolzano, BZ, Italy
Research Site
Forli, FC, Italy
Research Site
Ferrara, FE, Italy
Research Site
Firenze, 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
Milano, Italy
Research Site
Molise, Italy
Research Site
Rome, Italy

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Flore La Tour	AstraZeneca
Study Director:	Raffaele Sabia	AstraZeneca

More Information

Publications:

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

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.

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.

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.

Foster RH, Goa KL. Risperidone. A pharmacoeconomic review of its use in schizophrenia. Pharmacoeconomics. 1998 Jul;14(1):97-133. Review.

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.

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.

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

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.

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.

[No authors listed] The Scottish First Episode Schizophrenia Study. II. Treatment: pimozide versus flupenthixol. The Scottish Schizophrenia Research Group. Br J Psychiatry. 1987 Mar;150:334-8.

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

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

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.

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.

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.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01392482 History of Changes
Other Study ID Numbers:	NIS-NIT-XXX-2011/1
Study First Received:	June 29, 2011
Last Updated:	September 14, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by AstraZeneca:

Schizophrenia
Bipolar Disorder

Additional relevant MeSH terms:

Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013