Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00328978

Enrollment

330

Registered

2006-05-24

Start date

2003-10-31

Completion date

2005-09-30

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorders, Schizophrenia

Keywords

schizophrenia, schizoaffective disorders

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.

Interventions

DRUGQuetiapine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026