Trial record 17 of 2318 for:    schizophrenia

IBIS: Italian Burden of Illness on Schizophrenia & Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01392482
First received: June 29, 2011
Last updated: September 14, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Disease
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014