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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206115
First received: September 14, 2005
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Schizophrenic Disorder
Drug: Seroquel Sustained Release (SR)
Drug: Seroquel Immediate Release (IR)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 535
Study Start Date: November 2004
Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206115

Locations
Bulgaria
Research Site
Burgas, Bulgaria
Research Site
Russe, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Sofia- Novi Iskar, Bulgaria
Greece
Research Site
Athens, Greece
Research Site
Chania, Greece
Research Site
Corfu, Greece
Research Site
Thessaloniki, Greece
India
Research Site
Chennai, India
Research Site
Karnataka, India
Research Site
Lucknow, India
Research Site
New Delhi, India
Indonesia
Research Site
Jakarta, DKI Jakarta, Indonesia
Research Site
Bandung, West Java, Indonesia
Research Site
Surabaya, Indonesia
Philippines
Research Site
Cebu, Philippines
Research Site
Davao City, Philippines
Research Site
Mandaluyong City, Philippines
Research Site
Manila, Philippines
Research Site
Pasig, Philippines
Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Bucuresti, Romania
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
South Africa
Research Site
Johannesburg, Gauteng, South Africa
Research Site
Medunsa, Pretoria, South Africa
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00206115     History of Changes
Other Study ID Numbers: D1444C00132
Study First Received: September 14, 2005
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
India: Ministry of Health
Philippines: Bureau of Food and Drugs
Romania: State Institute for Drug Control
Russia: Pharmacological Committee, Ministry of Health
South Africa: Medicines Control Council

Keywords provided by AstraZeneca:
Schizophrenic disorder

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014