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Completed

NCT Number: NCT01959659

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Epping, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Medical resource utilization (in-/out-patient hospital services, community-based day service, other health care contacts) of patients with persistent symptoms of schizophrenia

    Time frame: in the 3 to 12 months prior to screening

Secondary outcomes

  1. Level/severity of schizophrenia symptoms: Clinical rating scales scores (PANSS, CGI-S, PSP, WoRQ, NSA-4, HoNOS)

    Time frame: Observational visit Day 1

  2. Patient health-related quality of life (HRQoL) questionnaires

    Time frame: Observational visit Day 1

  3. Caregiver's burden as assessed by questionnaires

    Time frame: Observational visit Day 1

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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