SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00206115
Collaborator
(none)
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Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
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
:
Nov 1, 2004
Actual Study Completion Date
:
Dec 1, 2005
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Burgas | Bulgaria | ||
| 2 | Research Site | Russe | Bulgaria | ||
| 3 | Research Site | Sofia- Novi Iskar | Bulgaria | ||
| 4 | Research Site | Sofia | Bulgaria | ||
| 5 | Research Site | Athens | Greece | ||
| 6 | Research Site | Chania | Greece | ||
| 7 | Research Site | Corfu | Greece | ||
| 8 | Research Site | Thessaloniki | Greece | ||
| 9 | Research Site | Chennai | India | ||
| 10 | Research Site | Karnataka | India | ||
| 11 | Research Site | Lucknow | India | ||
| 12 | Research Site | New Delhi | India | ||
| 13 | Research Site | Jakarta | DKI Jakarta | Indonesia | |
| 14 | Research Site | Bandung | West Java | Indonesia | |
| 15 | Research Site | Surabaya | Indonesia | ||
| 16 | Research Site | Cebu | Philippines | ||
| 17 | Research Site | Davao City | Philippines | ||
| 18 | Research Site | Mandaluyong City | Philippines | ||
| 19 | Research Site | Manila | Philippines | ||
| 20 | Research Site | Pasig | Philippines | ||
| 21 | Research Site | Brasov | Romania | ||
| 22 | Research Site | Bucharest | Romania | ||
| 23 | Research Site | Bucuresti | Romania | ||
| 24 | Research Site | Moscow | Russian Federation | ||
| 25 | Research Site | St. Petersburg | Russian Federation | ||
| 26 | Research Site | Johannesburg | Gauteng | South Africa | |
| 27 | Research Site | Medunsa | Pretoria | South Africa | |
| 28 | Research Site | Bloemfontein | South Africa | ||
| 29 | Research Site | Ga-Rankuwa | South Africa | ||
| 30 | Research Site | Johannesburg | South Africa | ||
| 31 | Research Site | Lyttelton Manor | South Africa | ||
| 32 | Research Site | Pretoria | South Africa |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: AstraZeneca CNS Medical Science Director, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00206115
Other Study ID Numbers:
- D1444C00132
First Posted:
Sep 21, 2005
Last Update Posted:
Jan 4, 2013
Last Verified:
Jan 1, 2013
Keywords provided by ,
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Additional relevant MeSH terms: