Overview

Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Quetiapine Fumarate
Criteria
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.