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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00206128




Registration number
NCT00206128
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
4/01/2013

Titles & IDs
Public title
Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
Scientific title
6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)
Secondary ID [1] 0 0
D1444C00146
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
Timepoint [1] 0 0
from randomisation to any visit
Secondary outcome [1] 0 0
The change in PANSS total score
Timepoint [1] 0 0
from randomization to week 6
Secondary outcome [2] 0 0
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
Timepoint [2] 0 0
from randomization to week 6
Secondary outcome [3] 0 0
The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4
Timepoint [3] 0 0
at week 6

Eligibility
Key inclusion criteria
* A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
* 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
* Patients with 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2006
Sample size
Target
Accrual to date
Final
454
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - QLD
Recruitment postcode(s) [1] 0 0
- QLD
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Burgas
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Radnevo
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Varna
Country [15] 0 0
Canada
State/province [15] 0 0
British Columbia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Canada
State/province [18] 0 0
Saskatchewan
Country [19] 0 0
Estonia
State/province [19] 0 0
Põltsamaa
Country [20] 0 0
Estonia
State/province [20] 0 0
Tallinn
Country [21] 0 0
Estonia
State/province [21] 0 0
Tartu
Country [22] 0 0
Finland
State/province [22] 0 0
Helsinki
Country [23] 0 0
Finland
State/province [23] 0 0
Mikkeli
Country [24] 0 0
Finland
State/province [24] 0 0
Turku
Country [25] 0 0
Germany
State/province [25] 0 0
Bayern
Country [26] 0 0
Germany
State/province [26] 0 0
Niedersachsen
Country [27] 0 0
Germany
State/province [27] 0 0
Nordrhein-Westfalen
Country [28] 0 0
Germany
State/province [28] 0 0
Thüringen
Country [29] 0 0
Germany
State/province [29] 0 0
Halle
Country [30] 0 0
Germany
State/province [30] 0 0
Marburg
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Debrecen
Country [33] 0 0
Hungary
State/province [33] 0 0
Gyula
Country [34] 0 0
Hungary
State/province [34] 0 0
Nagykálló
Country [35] 0 0
Hungary
State/province [35] 0 0
Szeged
Country [36] 0 0
Hungary
State/province [36] 0 0
Székesfehérvár
Country [37] 0 0
Italy
State/province [37] 0 0
BO
Country [38] 0 0
Italy
State/province [38] 0 0
CA
Country [39] 0 0
Italy
State/province [39] 0 0
PG
Country [40] 0 0
Italy
State/province [40] 0 0
TO
Country [41] 0 0
Italy
State/province [41] 0 0
VI
Country [42] 0 0
Italy
State/province [42] 0 0
Quartu Sant Elena
Country [43] 0 0
Latvia
State/province [43] 0 0
Riga
Country [44] 0 0
Latvia
State/province [44] 0 0
Sigulda
Country [45] 0 0
Lithuania
State/province [45] 0 0
Kaunas
Country [46] 0 0
Lithuania
State/province [46] 0 0
Klapeda
Country [47] 0 0
Lithuania
State/province [47] 0 0
Siauliai
Country [48] 0 0
Lithuania
State/province [48] 0 0
Vilnius
Country [49] 0 0
Spain
State/province [49] 0 0
Cádiz
Country [50] 0 0
Spain
State/province [50] 0 0
Madrid
Country [51] 0 0
Spain
State/province [51] 0 0
Villamartin

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Trial website
https://clinicaltrials.gov/study/NCT00206128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Seroquel Medical Science Director, MD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00206128