Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures * Patient has a documented clinical diagnosis of schizophrenia * Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit
Exclusion criteria
* Patients (female) must not be pregnant or lactating * Patients with a known intolerance or lack of response to previous treatment with quetiapine * Patients who have previously participated in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability | — |
Countries
Germany, India, Malaysia, Philippines, Poland, Russia, Serbia, South Africa, Ukraine, United States
Outcome results
None listed