Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia

A Non-interventional, Open Label, Phase IV Observational Study for the Safety and Efficacy of Switching to Quetiapine (Seroquel) in Outpatients With Schizophrenia Who Have Been Unsuccessfully Treated With Other Antipsychotics

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00690365

Acronym

Q-chase

Enrollment

576

Registered

2008-06-04

Start date

2007-06-30

Completion date

2008-04-30

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Switching, Quetiapine, schizophrenia, unsuccessfully treated, antipsychotics

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results