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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Seroquel (quetiapine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00228462

D1444C00004

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind