NCT00690365

Brief Summary

This is a single-arm, phase IV, open-label, prospective, non interventional study in approximately 600 patients that will be followed for 6 months in order to evaluate the safety and efficacy of quetiapine. Patients will be switched over a 4 to 7 day cross-titration period from their previous antipsychotic medication to quetiapine according to the approved SPC.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

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

June 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

10 months

First QC Date

June 2, 2008

Last Update Submit

December 8, 2010

Conditions

Schizophrenia

Keywords

SwitchingQuetiapineschizophreniaunsuccessfully treatedantipsychotics

Outcome Measures

Primary Outcomes (1)

  • Safety of quetiapine assessed through analysis of AE/SAE data (rate of patients presenting SAEs, rate of patients who discontinue treatment due to any AE, time to treatment discontinuation due to any AEs)

    5 visits (Day 0, Week 1, Week 4, Week 12, Week 24); SAEs will be reported during all study period

Secondary Outcomes (2)

  • Changes in the Clinical Global Impression of Severity and Improvement (CGI-S, CGI-I) and in Brief psychiatric Rating Scale (BPRS) from baseline to end of study treatment

    5 visits (Day 0, Week 1, Week 4, Week 12, Week 24)

  • Percentage of extra-pyramidal side effects assessed using the Simpson-Angus Scale (SAS)

    Changes from baseline to end of study treatment or (6 months) or early withdrawal

Eligibility Criteria

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

Primary Care

You may qualify if:

  • Diagnosis of schizophrenia at least 1 year prior to screening
  • Inadequate response or poor safety /tolerability or non-compliance to previous antipsychotic medication
  • Provision of Informed Consent prior to enrolment

You may not qualify if:

  • Known hypersensitivity to active substance of excipients
  • Patients receiving P450 3A4 inhibitors
  • Pregnancy or lactation
  • Substance abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

June 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

December 9, 2010

Record last verified: 2010-12