Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Seroquel (quetiapine) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Investigative Site, Sofia, Bulgaria
Investigative Site, Radnevo, Bulgaria
Investigative Site, Burgas, Bulgaria
Investigative Site, Bydgoszcz, Poland
Investigative Site, Tuszyn, Poland
Additional Information
Starting date: March 2005
Ending date: April 2006
Last updated: December 14, 2007
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