SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia

Condition(s) targeted: Schizophrenic Disorder

Intervention: Seroquel Sustained Release (SR) (Drug); Seroquel Immediate Release (IR) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca CNS Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

Efficacy

To demonstrate a higher PANSS response rate

To demonstrate superior Clinical Global Impressions (CGI) response

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- To be considered for this study the patients should be aged between 18 to 65 years,

need to suffer from schizophrenia and must be willing to participate.

Exclusion Criteria:

- Patients that suffer from psychiatric disorders other than schizophrenia including

drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.

Research Site, Burgas, Bulgaria

Research Site, Sofia, Bulgaria

Research Site, Russe, Bulgaria

Research Site, Sofia- Novi Iskar, Bulgaria

Research Site, Athens, Greece

Research Site, Chania, Greece

Research Site, Corfu, Greece

Research Site, Thessaloniki, Greece

Research Site, Chennai, India

Research Site, Karnataka, India

Research Site, Lucknow, India

Research Site, New Delhi, India

Research Site, Surabaya, Indonesia

Research Site, Cebu, Philippines

Research Site, Davao City, Philippines

Research Site, Mandaluyong City, Philippines

Research Site, Manila, Philippines

Research Site, Pasig, Philippines

Research Site, Brasov, Romania

Research Site, Bucharest, Romania

Research Site, Bucuresti, Romania

Research Site, Moscow, Russian Federation

Research Site, St. Petersburg, Russian Federation

Research Site, Bloemfontein, South Africa

Research Site, Ga-Rankuwa, South Africa

Research Site, Johannesburg, South Africa

Research Site, Lyttelton Manor, South Africa

Research Site, Pretoria, South Africa

Research Site, Jakarta, DKI Jakarta, Indonesia

Research Site, Johannesburg, Gauteng, South Africa

Research Site, Medunsa, Pretoria, South Africa

Research Site, Bandung, West Java, Indonesia

Starting date: November 2004
Last updated: November 1, 2006