A Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia to Describe Medical Resource Utilization and Burden of Illness

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01959659
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This non-interventional, cross-sectional survey and retrospective review will evaluate the medical resource utilization and burden of illness in patients who have persistent symptoms of schizophrenia despite receiving adequately dosed antipsychotic treatment and who have not had an acute exacerbation in the 3 months prior to enrolment. Medical records will be reviewed for a minimum of 3 months and up to 12 months prior to screening. Data collection at a single visit will include rating scales and questionnaires that reflect the clinical status and the quality of life of the patients and the economic impact of schizophrenia.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1431

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Patients who have a clinical diagnosis of schizophrenia as documented in their medical records
• Patients who, in the opinion of the investigator, have had on-going, persistent symptoms of schizophrenia for at least the last 3 months prior to enrolment
• Patients who, in the opinion of the investigator, have been prescribed adequate doses of antipsychotic treatment for at least the last 3 months
• Patient has adequate spoken local language

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Exclusion Criteria

• Acute exacerbation of schizophrenia within the last 3 months prior to enrolment
• Enrolment in an interventional study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia	in the 3 to 12 months prior to screening

Secondary Outcome Measures

Name	Time	Method
Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)	Observational visit Day 1
Patient health-related quality of life (HRQoL) questionnaires	Observational visit Day 1
Caregiver's burden as assessed by questionnaires	Observational visit Day 1