Safety and Efficacy of Switching to Quetiapine in Outpatients With Schizophrenia (Q-chase)

AstraZeneca

Status: Completed

Conditions: Schizophrenia

Study type: Observational

Funder types: Industry

Identifiers

NCT00690365

NIS-NGR-SER-2007/1

Details and patient eligibility

About

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.

Enrollment: 576 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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