Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorders

• Registration Number: NCT00328978
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to assess and compare the side effect profile, safety, tolerability and efficacy of schizophrenic or schizoaffective subjects non- or partially- responsive to 800 mg/day of quetiapine treated with either 800 mg/day or more than 800 mg/day of quetiapine during 8 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study Completion: 2005-09
• Study First Submitted: 2006-05-22
• Study First Submitted QC: 2006-05-22
• Study First Posted: 2006-05-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• Inclusion Criteria: Men and women, age 18-65 years with persistent positive or negative symptoms with a PANSS total score of ≥ 70 and < 110 and a Clinical Global Improvement (CGI)- Severity of Illness score of at least 4 (moderately ill) at screening. Subjects may be treated as in- or out-patients. Subjects must give written informed consent.

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Exclusion Criteria

• Subjects with other psychiatric, medical or behavioural comorbid disorder that may interfere with study conduct or interpretation.
• Female of childbearing potential, unless the subject is using a reliable method of contraception
• Subjects with alcohol or psychoactive-substance dependence not in full remission or with significant alcohol or substance abuse in the past 3 months will be excluded.
• Laboratory test results outside the range of reference considered by the investigator to be clinically significant.
• Inability to respect the visit schedule and known intolerance to quetiapine at 800mg/day.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the proportion of subjects (%) experiencing emergent or a worsening of EPS following treatment of quetiapine 800mg or higher than 800 mg/day in schizophrenic or schizoaffective subjects.

Secondary Outcome Measures

Name	Time	Method
To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.

Trial Locations

Locations (1)

Research Site; 🇨🇦 Saskatoon, Saskatchewan, Canada