Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00328978

Collaborator

(none)

330

Enrollment

Locations

Duration (Months)

19.4

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorders	Drug: Quetiapine	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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.

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	Calgary	Alberta	Canada
2	Research Site	Edmonton	Alberta	Canada
3	Research Site	West Claresholm	Alberta	Canada
4	Research Site	Victoria	British Columbia	Canada
5	Research Site	White Rock	British Columbia	Canada
6	Research Site	Winnipeg	Manitoba	Canada
7	Research Site	Sydney	Nova Scotia	Canada
8	Research Site	Kingston	Ontario	Canada
9	Research Site	London	Ontario	Canada
10	Research Site	Markham	Ontario	Canada
11	Research Site	Mississauga	Ontario	Canada
12	Research Site	Ottawa	Ontario	Canada
13	Research Site	Windsor	Ontario	Canada
14	Research Site	Montreal	Quebec	Canada
15	Research Site	Quebec City	Quebec	Canada
16	Research Site	Verdun	Quebec	Canada
17	Research Site	Saskatoon	Saskatchewan	Canada