Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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)

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

Secondary outcomes

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

Time frame: 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)

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: Q-chase

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jun 4, 2008
Registry last updated: Dec 9, 2010

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.

Published trials that share one or more normalized conditions with this study.

Completed