Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

AstraZeneca330 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

330

Conditions

Schizophrenia Schizoaffective Disorders

Interventions

QuetiapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (17)

Research Site

Calgary, Alberta, Canada

Research Site

Edmonton, Alberta, Canada

Research Site

West Claresholm, Alberta, Canada

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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