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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01959659

Enrollment

1431

Registered

2013-10-10

Start date

2013-05-31

Completion date

2014-04-30

Last updated

2016-11-02

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

Conditions

Schizophrenia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Australia, Czechia, France, Italy, Russia, Spain, Turkey (Türkiye)

Outcome results