Overview

Study of Efficacy and Safety of Seroquel (Quetiapine Fumarate) as Mono-Therapy for Acute Schizophrenic

Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Quetiapine Fumarate
Criteria
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