Back to resultsRelapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Seroquel (quetiapine)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia
Eligibility Criteria
Inclusion Criteria: Stable schizophrenic patients who have provided written informed consent Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine). Exclusion Criteria: Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate, Expected non-compliance to treatment Known diabetes mellitus, Contraindications, Intolerance or non-responsiveness to Seroquel or other safety issues.
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Outcomes
Primary Outcome Measures
The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
Secondary Outcome Measures
To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00228462
Brief Title
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Official Title
A 1-year, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo (Abbreviated)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Seroquel (quetiapine)
Primary Outcome Measure Information:
Title
The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
Secondary Outcome Measure Information:
Title
To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable schizophrenic patients who have provided written informed consent
Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine).
Exclusion Criteria:
Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate,
Expected non-compliance to treatment
Known diabetes mellitus,
Contraindications,
Intolerance or non-responsiveness to Seroquel or other safety issues.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Burgas
Country
Bulgaria
Facility Name
Investigative Site
City
Radnevo
Country
Bulgaria
Facility Name
Investigative Site
City
Sofia
Country
Bulgaria
Facility Name
Investigative Site
City
Bydgoszcz
Country
Poland
Facility Name
Investigative Site
City
Tuszyn
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
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