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

January 3, 2013 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

535

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Sofia- Novi Iskar, Bulgaria
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Chania, Greece
        • Research Site
      • Corfu, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • India
      • Chennai, India
        • Research Site
      • Karnataka, India
        • Research Site
      • Lucknow, India
        • Research Site
      • New Delhi, India
        • Research Site
  • Indonesia
      • Surabaya, Indonesia
        • Research Site
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia
        • Research Site
    • West Java
      • Bandung, West Java, Indonesia
        • Research Site
  • Philippines
      • Cebu, Philippines
        • Research Site
      • Davao City, Philippines
        • Research Site
      • Mandaluyong City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
      • Pasig, Philippines
        • Research Site
  • Romania
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Bucuresti, Romania
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • South Africa
      • 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
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Research Site
    • Pretoria
      • Medunsa, Pretoria, South Africa
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
Efficacy
To demonstrate a higher PANSS response rate
To demonstrate superior Clinical Global Impressions (CGI) response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca CNS Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1444C00132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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