Trials / Completed
CompletedNCT00206115
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 535 (planned)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Seroquel Sustained Release (SR) | |
| DRUG | Seroquel Immediate Release (IR) | |
| DRUG | Placebo |
Timeline
- Start date
- 2004-11-01
- Completion
- 2005-12-01
- First posted
- 2005-09-21
- Last updated
- 2013-01-04
Locations
31 sites across 8 countries: Bulgaria, Greece, India, Indonesia, Philippines, Romania, Russia, South Africa
Source: ClinicalTrials.gov record NCT00206115. Inclusion in this directory is not an endorsement.