Schizophrenia
Conditions
Brief summary
The primary objective of the study is to evaluate the efficacy of quetiapine fumarate (Seroquel) with daily dose 600mg-750mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline in PANSS total score at Day 56 using the last observation carried forward (LOCF) method.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Provision of written informed consent for study participation before initiation of any study related procedures, signed by the patient's legal guardian * Female and/or male, aged between 18 and 60 years (inclusive) * Is hospitalised in a psychiatric unit with an acute episode of schizophrenia defined by CCMD-3 criteria as one of the following: \[20.1\] paranoid schizophrenia, \[20.2\] hebephrenic schizophrenia, \[20.3\] catatonic schizophrenia, \[20.5\] undifferentiated schizophrenia
Exclusion criteria
* CCMD-3 diagnosis of mental retardation * Psychosis judged to be the direct physiological effect of an abused medication or substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in PANSS total score at Day 56 (LOCF) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PANSS positive scale score at Day 56 (LOCF) | — |
| Change from baseline in PANSS negative scale score at Day 56 (LOCF) | — |
| Change from baseline in PANSS EC score at day 56 , | — |
| Change from baseline in MADRS total score at Day 56. etc | — |
Countries
China
Outcome results
None listed