Seroquel STACK Study in Schizophrenic or Schizoaffective Subjects

NCT ID: NCT00328978

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Schizoaffective Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Canada Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Calgary, Alberta, Canada

Site Status

Research Site

Edmonton, Alberta, Canada

Site Status

Research Site

West Claresholm, Alberta, Canada

Site Status

Research Site

Victoria, British Columbia, Canada

Site Status

Research Site

White Rock, British Columbia, Canada

Site Status

Research Site

Winnipeg, Manitoba, Canada

Site Status

Research Site

Sydney, Nova Scotia, Canada

Site Status

Research Site

Kingston, Ontario, Canada

Site Status

Research Site

London, Ontario, Canada

Site Status

Research Site

Markham, Ontario, Canada

Site Status

Research Site

Mississauga, Ontario, Canada

Site Status

Research Site

Ottawa, Ontario, Canada

Site Status

Research Site

Windsor, Ontario, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Research Site

Québec, Quebec, Canada

Site Status

Research Site

Verdun, Quebec, Canada

Site Status

Research Site

Saskatoon, Saskatchewan, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Honer WG, MacEwan GW, Gendron A, Stip E, Labelle A, Williams R, Eriksson H; STACK Study Group. A randomized, double-blind, placebo-controlled study of the safety and tolerability of high-dose quetiapine in patients with persistent symptoms of schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2012 Jan;73(1):13-20. doi: 10.4088/JCP.10m06194. Epub 2011 Jun 14.

Reference Type DERIVED
PMID: 21733490 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1441C00023

Identifier Type: -

Identifier Source: secondary_id

DC-990-0165

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.