Who is sponsoring NCT00206115?

NCT00206115 is sponsored by AstraZeneca.

What condition does NCT00206115 study?

NCT00206115 studies Schizophrenic Disorder.

What drugs are being tested in NCT00206115?

Interventions: Seroquel Sustained Release (SR), Seroquel Immediate Release (IR), Placebo.

What is the status of NCT00206115?

NCT00206115 is currently COMPLETED.

Last reviewed 2013-01-03 · How we verify

A 6-week, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy & Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

NCT00206115 Phase 3 COMPLETED

The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia. 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	535
Start date	2004-11
Completion	2005-12

Conditions

Schizophrenic Disorder

Interventions

Seroquel Sustained Release (SR)
Seroquel Immediate Release (IR)
Placebo

Primary outcomes

The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.

Countries

Bulgaria, Greece, India, Indonesia, Philippines, Romania, Russia, South Africa