Schizophrenia
Conditions
Keywords
Schizophrenia
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.
Interventions
DRUGIR (Immediate-Release) quetiapine fumarate (drug)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number and type of adverse events | — |
| Changes in vital signs and weight | — |
| Safety and Tolerability | — |
| Change of Simpson-Angus Scale (SAS) score | — |
| Change of Barnes Akathisia Rating Scale (BARS) score | — |
| Clinically significant changes in ECG (reported as AE) | — |
Countries
Germany
Outcome results
None listed