Completed

A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

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What is being tested

Data Collection

Who is being recruted

Mental Disorders

+ Schizophrenia

+ Schizophrenia Spectrum and Other Psychotic Disorders

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia 
NCT00085891
Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

535 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 26 locations

Suspended

Research Site

Birmingham, United StatesSee the location
Suspended

Research Site

Cerritos, United States
Suspended

Research Site

San Diego, United States
Suspended

Research Site

Santa Ana, United States
Completed26 Study Centers