Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo - Tabular View

Tracking Information

First Received Date ^ICMJE

September 27, 2005

Last Updated Date

December 14, 2007

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year

Original Primary Outcome Measures ^ICMJE

The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating
relapse prevention in long-term use in patients with schizophrenia as measured by the time to
first psychiatric relapse up to one year

Change History

Complete list of historical versions of study NCT00228462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate

Original Secondary Outcome Measures ^ICMJE

To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse
in long-term use in patients with schizophrenia by evaluating the one-year relapse rate

Descriptive Information

Brief Title ^ICMJE

Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo

Official Title ^ICMJE

A 1-Year, Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-Release Quetiapine Fumarate (SEROQUEL) or Placebo (Abbreviated)

Brief Summary

This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Seroquel (quetiapine)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

197

Completion Date

April 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Stable schizophrenic patients who have provided written informed consent
Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine).

Exclusion Criteria:

Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate,
Expected non-compliance to treatment
Known diabetes mellitus,
Contraindications,
Intolerance or non-responsiveness to Seroquel or other safety issues.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bulgaria, Poland

Administrative Information

NCT ID ^ICMJE

NCT00228462

Responsible Party

Study ID Numbers ^ICMJE

D1444C00004

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Seroquel Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP