IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

NCT01392482 | Completed

• 1 other identifier: NIS-NIT-XXX-2011/1
• Study Type: observational
• Target: 751,725
• Locations: 1 country
• Sites: 16

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.

Conditions

Schizophrenia; Bipolar Disorder

Keywords

Schizophrenia; Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Describe the costs of illness of patients with schizophrenia or bipolar disorder

  Index Data up to 18 months

• To evaluate adherence level for patients treated with antipsychotics

  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.

  Index Data up to 18 months

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients from 40 LHU

You may qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (16)

Research Site

Arezzo, AR, Italy

Location

Research Site

Bergamo, BG, Italy

Location

Research Site

Bolzano, BZ, Italy

Location

Research Site

Forlì, FC, Italy

Location

Research Site

Ferrara, FE, Italy

Location

Research Site

Florence, FI, Italy

Location

Research Site

Lecce, LE, Italy

Location

Research Site

Matera, MT, Italy

Location

Research Site

Monza E Brianza, MZ, Italy

Location

Research Site

Piacenza, PC, Italy

Location

Research Site

Ravenna, RA, Italy

Location

Research Site

Ragusa, RG, Italy

Location

Research Site

Teramo, TE, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Molise, Italy

Location

Research Site

Rome, Italy

Location

Related Publications (17)

• Brown S. Excess mortality of schizophrenia. A meta-analysis. Br J Psychiatry. 1997 Dec;171:502-8. doi: 10.1192/bjp.171.6.502.

  PMID: 9519087 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.

  PMID: 8275890 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.

  PMID: 7906710 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.

  PMID: 11465308 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.

  PMID: 10182198 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.

  PMID: 3083800 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.

  PMID: 8911225 BACKGROUND

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

  PMID: 10826667 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.

  PMID: 2250501 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.

  PMID: 9846389 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.

  PMID: 2889495 BACKGROUND

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

  PMID: 2873851 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.

  PMID: 1357703 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.

  PMID: 9585716 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.

  PMID: 16464201 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.

  PMID: 15292538 BACKGROUND

• 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.

  PMID: 25312446 DERIVED

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Flore La Tour

  AstraZeneca

  STUDY CHAIR

• Raffaele Sabia

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

IT (16)