Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Schizoaffective Disorders

Schizophrenia

Treatments

Drug: Quetiapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00328978

DC-990-0165

D1441C00023

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.