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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.
 
ClinicalTrials.gov Identifier: NCT00206115
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 4, 2013
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2006)
  • Efficacy
  • To demonstrate a higher PANSS response rate
  • To demonstrate superior Clinical Global Impressions (CGI) response
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • Efficacy
  • To demonstrate a higher PANSS response rate
  • To demonstrate superior CGI response
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenic Disorder
Intervention  ICMJE
  • Drug: Seroquel Sustained Release (SR)
  • Drug: Seroquel Immediate Release (IR)
  • Drug: Placebo
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 14, 2005)
535
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Greece,   India,   Indonesia,   Philippines,   Romania,   Russian Federation,   South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00206115
Other Study ID Numbers  ICMJE D1444C00132
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
PRS Account AstraZeneca
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP