IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Study Overview
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Brief Summary
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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.

Official Title
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IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Conditions
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Schizophrenia, Bipolar Disorder

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment with antipsychotics<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Bipolar Disorder