Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients (ESPRIT)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Chlorpromazine; Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00882518

D1444C00008

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.

Enrollment: 388 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Schizophrenia diagnosis
• Provision of written informed consent before initiation of any study

Exclusion criteria

• AIDS and hepatitis B
• History of seizure disorder
• Hospitalisation for schizophrenic more than 1 month immediately before enter into study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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388 participants in 2 patient groups

1-Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

Experimental group

Description:

Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) extended-release (300 mg/1st day, 600 mg/2nd day, 400 or 600 or 800 mg/3-42 day)

Treatment:

Drug: Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)

2-Chlorpromazine

Active Comparator group

Description:

Chlorpromazine (50 or 100 mg/1st day; 100-200 mg/2nd day; 150-300 mg/3rd day; 200-400 mg/4th day; 300 or 400 or 500 or 600 mg/5-42 days)

Treatment:

Drug: Chlorpromazine