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Completed

NCT Number: NCT00981123

Non-interventional (NI) Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia

Observational, non-comparative, epidemiological study to collect and analyse real life data on schizophrenic patients receiving quetiapine according to the standard medical practice in Croatia. The main objectives are to assess after 6 months of quetiapine therapy severity of illness and global improvement in patients using Clinical Global Impression (CGI) scale.

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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

Research Site, Bjelovar, Croatia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with diagnosis of schizophrenia
  • Patients who are already treated with quetiapine for at least 12 weeks (outpatients or hospitalised patients)
  • Patients capable of signing ICF

Exclusion criteria

  • Patients with hypersensitivity to active substance or any of the excipients of this product
  • Patients with contraindication for quetiapine therapy according to the approved SmPC

Treatment and study plan

Primary outcomes

  1. To assess severity of illness and global improvement in patients after 6 months of quetiapine therapy using Clinical Global Impression (CGI) scale

    Time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)

Secondary outcomes

  1. To measure therapeutic response in schizophrenic patients using BPRS scale

    Time frame: BPRS - 2 measures (after 3 and after 6 months of quetiapine therapy)

  2. To evaluate compliance with the prescribed antipsychotic treatment

    Time frame: CGI - 2 measures (after 3 and after 6 months of quetiapine therapy)

  3. To evaluate prescribing practices for quetiapine in the treatment of schizophrenia in Croatia

    Time frame: 3 measures (at the time of quetiapine therapy introduction, after 3 and 6 m of quetiapine therapy)

  4. To evaluate type and frequency of concomitant therapy

    Time frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in concomitant therapy

  5. To evaluate average number of hospitalisations

    Time frame: At visit 1 ( day 0) and visit 2 (day 90) recorded all changes in numbers of hospitalisations

  6. To evaluate frequency of mental illnesses in patient's family

    Time frame: at visit 1 (day 0)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Non-interventional Study to Observe Efficacy and Usage of Quetiapine in Acute Episodes of Schizophrenia and as Maintenance Therapy Following Standard Clinical Practice in Croatia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2009
Registry last updated
Jan 10, 2011

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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