Schizophrenia
Conditions
Keywords
Schizophrenia, Schizophrenic disorder
Brief summary
The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.
Interventions
DRUGQuetiapine Fumarate
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
* Patient is able to provide written informed consent before beginning any study related procedures * Patient has a documented clinical diagnosis of schizophrenia * Patient is able to understand and comply with the requirements of the study, as judged by a study investigator
Exclusion criteria
* Patients with a history of non-compliance as judged by the study investigator * Patients with a known lack of response to previous treatment with quetiapine * Patients who have participated in another drug study within 4 weeks prior to enrollment into this study * Patients who have previously participated in this study or study D1444C00132
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline. | — |
Countries
United States
Outcome results
None listed