Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) (QUENCH)

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Quetiapine Fumarate XR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00779506

D1443L00062

Details and patient eligibility

About

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Enrollment

96 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
PANSS total score of at least 70 at enrolment and at assignment Day 1
CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks

Exclusion criteria

Known intolerance or lack of response to quetiapine fumarate
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
Substance or alcohol dependence at enrolment
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment