Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 14, 2005
January 3, 2013
November 2004
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00206115 on ClinicalTrials.gov Archive Site
  • Efficacy
  • To demonstrate a higher PANSS response rate
  • To demonstrate superior Clinical Global Impressions (CGI) response
  • Efficacy
  • To demonstrate a higher PANSS response rate
  • To demonstrate superior CGI response
Not Provided
Not Provided
 
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenic Disorder
  • Drug: Seroquel Sustained Release (SR)
  • Drug: Seroquel Immediate Release (IR)
  • Drug: Placebo
Not Provided
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.
 
Completed
535
December 2005
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Greece,   India,   Indonesia,   Philippines,   Romania,   Russian Federation,   South Africa
 
NCT00206115
D1444C00132
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca CNS Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

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