IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Completed

• Conditions: Schizophrenia; Bipolar Disorder

• Registration Number: NCT01392482
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-29
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-11
• Study First Posted: 2011-07-12
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-14
• Last Update Posted: 2012-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751725

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Index Data up to 18 months	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

Name	Time	Method
Describe the costs of illness of patients with schizophrenia or bipolar disorder	Index Data up to 18 months	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	Index Data up to 18 months	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.	Index Data up to 18 months	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

Trial Locations

Locations (1)

Research Site; 🇮🇹 Rome, Italy