NCT00921362

Brief Summary

Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,387

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2006

Shorter than P25 for all trials

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

May 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

First QC Date

June 15, 2009

Last Update Submit

June 15, 2009

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Brief Psychiatric Rating Scale - BPRS

    Monthly at every clinic visit- 7 times

Secondary Outcomes (2)

  • Clinical Global Impression Severity of Illness

    Monthly/ at every clinic visit-7 times

  • CGI-S Clinical Global Impression Improvement CGI -I

    Monthly/ at every clinic visit except first visit- 6 times

Study Arms (1)

1

Schizophrenia patients under Seroquel treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients eligible for entry into the study will have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature

You may qualify if:

  • To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
  • To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool

You may not qualify if:

  • All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • stina Pentiuc, Med Director

    AstraZeneca Romania

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

May 1, 2006

Study Completion

January 1, 2007

Last Updated

June 16, 2009

Record last verified: 2009-06