Clinical trial NCT00227305: Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Official title: A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schizophrenia (Abbreviated)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Bipolar I Disorder
Keywords: Schizophrenia
Bipolar I Disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-28
Enrollment: 381
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.


Eligibility criteria: Inclusion Criteria:

* Patient is able to provide written assent and the parents or legal guardian of the patient are/is able to provide written informed consent before beginning any study related procedures
* Patient previously enrolled in either double-blind Study D1441C00149 or D1441C00112
* Patient has documented clinical diagnosis of schizophrenia or bipolar I disorder
* Patient's parent or legal guardian will be able to accompany the patient to each scheduled study visit

Exclusion Criteria:

* Patients (female) must not be pregnant or lactating
* Patients with a known intolerance or lack of response to previous treatment with quetiapine
* Patients who have previously participated in this study

Primary outcomes:
measure: Incidence and Nature of Adverse Events (AEs)
timeFrame: from open label to week 26+ 30 days
measure: Number of Patients Withdrawn Due to AEs.
timeFrame: during 26 weeks of treatment
measure: Changes in Laboratory Test Results (Prolactin)
timeFrame: Duration of study participation
measure: Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
timeFrame: OL baseline to week 26
measure: Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
timeFrame: 26 weeks of treatment
measure: Change From Baseline in Weight
timeFrame: 26 weeks of treatment
measure: Change From Baseline in Supine Pulse
timeFrame: OL baseline to week 26
measure: Change From OL Baseline in Supine Systolic BP.
timeFrame: OL baseline to Week 26
measure: Change From OL Baseline in Supine Diastolic BP.
timeFrame: OL baseline to Week 26
Secondary outcomes:
measure: Changes in Tanner Stage
timeFrame: Change from OL baseline to week 26 in the Tanner stage
measure: Change From Baseline in Children's Global Assessment Scale (CGAS) Score
timeFrame: OL Baseline to Week 26
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Cerritos
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Altamonte Springs
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Oak Brook
country: United States
facility: Research Site
state: Illinois
city: Newton
country: United States
facility: Research Site
state: Kansas
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Rochester
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Lyndhurst
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Virginia Beach
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
city: Lucknow
country: India
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Petaling Jaya
country: Malaysia
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Mandaluyong City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Kharkov
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Findling RL, Pathak S, Earley WR, Liu S, DelBello M. Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study. J Child Adolesc Psychopharmacol. 2013 Sep;23(7):490-501. doi: 10.1089/cap.2012.0092. Epub 2013 Sep 11.