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

Schizophrenic Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206115
• Other study ID #: D1444C00132
• Status: Completed
• Phase: Phase 3
• First received: September 14, 2005
• Last updated: January 3, 2013
• Start date: November 2004
• Est. completion date: December 2005

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyGreece: National Organization of MedicinesIndia: Ministry of HealthPhilippines: Bureau of Food and DrugsRomania: State Institute for Drug ControlRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Schizophrenic Disorder

Intervention

Drug:
• Seroquel Sustained Release (SR)

• Seroquel Immediate Release (IR)

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Greece,  India,  Indonesia,  Philippines,  Romania,  Russian Federation,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Efficacy
Secondary	To demonstrate a higher PANSS response rate
Secondary	To demonstrate superior Clinical Global Impressions (CGI) response