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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Quetiapine Fumarate (Seroquel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00428350

SOLO

D1443L00004

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)