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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228462
• Other study ID #: D1444C00004
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: January 3, 2013
• Start date: March 2005
• Est. completion date: April 2006

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Seroquel (quetiapine)

Locations

Country	Name	City	State
Bulgaria	Investigative Site	Burgas
Bulgaria	Investigative Site	Radnevo
Bulgaria	Investigative Site	Sofia
Poland	Investigative Site	Bydgoszcz
Poland	Investigative Site	Tuszyn

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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