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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206115
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2013
Information provided by:

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.

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 535 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Primary Outcome Measures :
  1. 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 :
  1. Efficacy
  2. To demonstrate a higher PANSS response rate
  3. To demonstrate superior Clinical Global Impressions (CGI) response

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206115

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00206115    
Other Study ID Numbers: D1444C00132
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: January 2013
Keywords provided by AstraZeneca:
Schizophrenic disorder
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs