Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

Schizophrenia Clinical Trial

Official title:

A Canadian, Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment With Higher Doses of Quetiapine Fumarate (Seroquel®) Greater Than 800 mg/Day in Schizophrenic or Schizoaffective Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328978
• Other study ID #: DC-990-0165
• Secondary ID: D1441C00023
• Status: Completed
• Phase: Phase 3
• First received: May 22, 2006
• Last updated: March 24, 2009
• Start date: October 2003
• Est. completion date: September 2005

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorders
• Schizophrenia

Intervention

Drug:
• Quetiapine

Locations

Country	Name	City	State
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Kingston	Ontario
Canada	Research Site	London	Ontario
Canada	Research Site	Markham	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec City	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Sydney	Nova Scotia
Canada	Research Site	Verdun	Quebec
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	West Claresholm	Alberta
Canada	Research Site	White Rock	British Columbia
Canada	Research Site	Windsor	Ontario
Canada	Research Site	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the safety, tolerability and efficacy of treatment with quetiapine in with doses higher than 800 mg/day in schizophrenic or schizoaffective subjects.