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

This study has been completed.

First Received: September 27, 2005 Last Updated: December 14, 2007 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00228462

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Seroquel (quetiapine)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	197
Study Start Date:	March 2005
Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228462

Locations

Bulgaria
Investigative Site
Sofia, Bulgaria
Investigative Site
Radnevo, Bulgaria
Investigative Site
Burgas, Bulgaria
Poland
Investigative Site
Bydgoszcz, Poland
Investigative Site
Tuszyn, Poland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Seroquel Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D1444C00004
Study First Received:	September 27, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00228462 History of Changes
Health Authority:	European Union: European Medicines Agency; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 03, 2009