Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

AstraZeneca535 enrolled

Overview

The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

535

Conditions

Schizophrenia

Interventions

Quetiapine FumarateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is able to provide written informed consent before beginning any study related procedures * Patient has a documented clinical diagnosis of schizophrenia * Patient is able to understand and comply with the requirements of the study, as judged by a study investigator Exclusion Criteria: * Patients with a history of non-compliance as judged by the study investigator * Patients with a known lack of response to previous treatment with quetiapine * Patients who have participated in another drug study within 4 weeks prior to enrollment into this study * Patients who have previously participated in this study or study D1444C00132

Locations (29)

Research Site

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.

Secondary Outcomes

Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.

Data from ClinicalTrials.gov

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