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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00228462
First received: September 27, 2005
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
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
Burgas, Bulgaria
Investigative Site
Radnevo, Bulgaria
Investigative Site
Sofia, 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

ClinicalTrials.gov Identifier: NCT00228462     History of Changes
Other Study ID Numbers: D1444C00004
Study First Received: September 27, 2005
Last Updated: January 3, 2013
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013