Schizophrenia Clinical Trial
Official 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)
Verified date | January 2013 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 454 |
Est. completion date | February 2006 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | QLD | |
Bulgaria | Research Site | Burgas | |
Bulgaria | Research Site | Radnevo | |
Bulgaria | Research Site | Varna | |
Canada | Research Site | Aurora | Ontario |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Mississauga | Ontario |
Canada | Research Site | Orleans | Ontario |
Canada | Research Site | Prince Albert | Saskatchewan |
Canada | Research Site | Quebec | |
Canada | Research Site | Sherbrooke | Quebec |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
Estonia | Research Site | Põltsamaa | |
Estonia | Research Site | Tallinn | |
Estonia | Research Site | Tartu | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Mikkeli | |
Finland | Research Site | Turku | |
Germany | Research Center | Aachen | Nordrhein-Westfalen |
Germany | Research Site | Aachen | Nordrhein-Westfalen |
Germany | Research Site | Göttingen | Niedersachsen |
Germany | Research Site | Halle | |
Germany | Research Site | Jena | Thüringen |
Germany | Research Site | Marburg | |
Germany | Research Site | München | Bayern |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Debrecen | |
Hungary | Research Site | Gyula | |
Hungary | Research Site | Nagykálló | |
Hungary | Research Site | Szeged | |
Hungary | Research Site | Székesfehérvár | |
Italy | Research Site | Bassano Del Grappa | VI |
Italy | Research Site | Bologna | BO |
Italy | Research Site | Cagliari | CA |
Italy | Research Site | Citta' di Castello | PG |
Italy | Research Site | Ellera di Corciano | PG |
Italy | Research Site | Quartu Sant Elena | |
Italy | Research Site | Torino | TO |
Latvia | Research Site | Riga | |
Latvia | Research Site | Sigulda | |
Lithuania | Research Site | Klapeda | |
Lithuania | Research Site | Siauliai | |
Lithuania | Research Sitte | Vilnius | |
Lithuania | Research Site | Ziegzdrai | Kaunas |
Spain | Research Site | Alcobendas | Madrid |
Spain | Research Site | Colmenar Viejo | Madrid |
Spain | Research Site | Jerez de la Frontera | Cádiz |
Spain | Research Site | Madrid | |
Spain | Research Site | Mostoles | Madrid |
Spain | Research Site | Villamartin | |
United States | Research Site | Anaheim | California |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Austin | Texas |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Cerritos | California |
United States | Research Site | Clementon | New Jersey |
United States | Research Site | Garden Grove | California |
United States | Research Site | Hoffman Estates | Illinois |
United States | Research Site | Houston | Texas |
United States | Research Site | Jackson | Mississippi |
United States | Research Site | National City | California |
United States | Research Site | New Orleans | Louisiana |
United States | Research Site | North Miami | Florida |
United States | Research Site | Pasadena | California |
United States | Research Site | Richmond | Virginia |
United States | Research Site | San Diego | California |
United States | Research Site | Santa Ana | California |
United States | Research Site | Staten Island | New York |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Australia, Bulgaria, Canada, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | from randomisation to any visit | No | |
Secondary | The change in PANSS total score | from randomization to week 6 | No | |
Secondary | The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively | from randomization to week 6 | No | |
Secondary | The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4 | at week 6 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |