Clinical trial NCT00234377: Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia
Official title: A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching Any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL®) in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to document the clinical benefit of quetiapine (Seroquel) sustained release (SR) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Patients who in their own and/or in the Investigator's opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.
* Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
* Able to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

* Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
* Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
* Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the Investigator.
* Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others.

Primary outcomes:
measure: The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability
Secondary outcomes:
measure: The change from baseline in Clinical Global Impression (CGI)-CB score
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Aurora
country: Canada
facility: Research Site
state: Ontario
city: Burlington
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Orleans
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Saint-Laurent
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Prince Albert
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Mikkeli
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
state: Bayern
city: Gottingen
country: Germany
facility: Research Site
state: Niedersachsen
city: Aachen
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: Saarbrucken
country: Germany
facility: Research Site
state: Saarland
city: Aachen
country: Germany
facility: Research Site
city: Gottingen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Homburg
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Szekesfehervar
country: Hungary
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca CNS Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Ganesan S, Agambaram V, Randeree F, Eggens I, Huizar K, Meulien D; Study 147 Investigators. Switching from other antipsychotics to once-daily extended release quetiapine fumarate in patients with schizophrenia. Curr Med Res Opin. 2008 Jan;24(1):21-32. doi: 10.1185/030079908x253384.