Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients
Phase 2
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00254787
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Men and women age ≥18 to ≤65 years with acute schizophrenia
- Provision of written informed consent prior to enrolment
Exclusion Criteria
- Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
- Patients with substance dependence
- Female patients who are pregnant, lactating or at risk of pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients who discontinue the study treatment due to adverse events (AEs) during the first week (day 1 to day 7) of treatment
- Secondary Outcome Measures
Name Time Method Safety and Tolerability Number and type of adverse events Changes in vital signs and weight Clinically significant changes in ECG (reported as AE) Change of Simpson-Angus Scale (SAS) score Change of Barnes Akathisia Rating Scale (BARS) score
Trial Locations
- Locations (1)
Research Site
🇩🇪Werneck, Germany