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IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01392482
Acronym
IBIS
Enrollment
751725
Registered
2011-07-12
Start date
2011-07-31
Completion date
2012-09-30
Last updated
2012-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Schizophrenia

Keywords

Schizophrenia, Bipolar Disorder

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.

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 patientsIndex Data up to 18 monthsThe 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

MeasureTime frameDescription
Describe the costs of illness of patients with schizophrenia or bipolar disorderIndex Data up to 18 monthsThe 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 antipsychoticsIndex Data up to 18 monthsThe 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 monthsThe 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026