Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Phase 3
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00228462
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 197
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Investigative Site
🇵🇱Tuszyn, Poland