NCT00981123

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

January 10, 2011

Status Verified

January 1, 2011

Enrollment Period

7 months

First QC Date

September 14, 2009

Last Update Submit

January 7, 2011

Conditions

Schizophrenia

Outcome Measures

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

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

Secondary Outcomes (6)

  • To measure therapeutic response in schizophrenic patients using BPRS scale

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

  • To evaluate compliance with the prescribed antipsychotic treatment

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

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

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

  • To evaluate type and frequency of concomitant therapy

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

  • To evaluate average number of hospitalisations

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

  • +1 more secondary outcomes

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients or hospitalised patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Research Site

Bjelovar, Croatia

Location

Research Site

Čakovec, Croatia

Location

Research Site

Dubrovnik, Croatia

Location

Research Site

Karlovac, Croatia

Location

Research Site

Osijek, Croatia

Location

Research Site

Popovača, Croatia

Location

Research Site

Pula, Croatia

Location

Research Site

Rijeka, Croatia

Location

Research Site

Sisak, Croatia

Location

Research Site

Slavonski Brod, Croatia

Location

Research Site

Split, Croatia

Location

Research Site

Šibenik, Croatia

Location

Research Site

Varaždin, Croatia

Location

Research Site

Vinkovci, Croatia

Location

Research Site

Vukovar, Croatia

Location

Research Site

Zabok, Croatia

Location

Research Site

Zadar, Croatia

Location

Research Site

Zagreb, Croatia

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ana Marija Gjurovic, MD, MSc

    AstraZeneca Medical Department

    STUDY DIRECTOR

  • Andreja Hasenohrl, DVM

    AstraZeneca Medical Department

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 22, 2009

Study Start

September 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

January 10, 2011

Record last verified: 2011-01

Locations

CR(18)