6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)

NCT00206128 Phase 3 COMPLETED

The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	454
Start date	2004-11
Completion	2006-02

Conditions

• Schizophrenia

Interventions

• Seroquel SR

Primary outcomes

• The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more — from randomisation to any visit

Countries

United States, Australia, Bulgaria, Canada, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Spain