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

Primary Purpose

Schizophrenic Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seroquel Sustained Release (SR)
Seroquel Immediate Release (IR)
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenic Disorder focused on measuring Schizophrenic disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 14, 2005
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206115
Brief Title
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With 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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenic Disorder
Keywords
Schizophrenic disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
535 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Seroquel Sustained Release (SR)
Intervention Type
Drug
Intervention Name(s)
Seroquel Immediate Release (IR)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Efficacy
Title
To demonstrate a higher PANSS response rate
Title
To demonstrate superior Clinical Global Impressions (CGI) response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca CNS Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Burgas
Country
Bulgaria
Facility Name
Research Site
City
Russe
Country
Bulgaria
Facility Name
Research Site
City
Sofia- Novi Iskar
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Chania
Country
Greece
Facility Name
Research Site
City
Corfu
Country
Greece
Facility Name
Research Site
City
Thessaloniki
Country
Greece
Facility Name
Research Site
City
Chennai
Country
India
Facility Name
Research Site
City
Karnataka
Country
India
Facility Name
Research Site
City
Lucknow
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Jakarta
State/Province
DKI Jakarta
Country
Indonesia
Facility Name
Research Site
City
Bandung
State/Province
West Java
Country
Indonesia
Facility Name
Research Site
City
Surabaya
Country
Indonesia
Facility Name
Research Site
City
Cebu
Country
Philippines
Facility Name
Research Site
City
Davao City
Country
Philippines
Facility Name
Research Site
City
Mandaluyong City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Pasig
Country
Philippines
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Medunsa
State/Province
Pretoria
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
Country
South Africa
Facility Name
Research Site
City
Ga-Rankuwa
Country
South Africa
Facility Name
Research Site
City
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Lyttelton Manor
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
17592906
Citation
Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, Andersson HM, Meulien D; Study 132 Investigators. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603.
Results Reference
derived

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

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