Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder

Schizophrenia Clinical Trial

— ANCHOR 150  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00227305
• Other study ID #: D1441C00150
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2005
• Last updated: January 3, 2013
• Start date: August 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 17 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar I Disorder
• Schizophrenia

Intervention

Drug:
• quetiapine fumarate
Oral dosing, flexible dosing

Locations

Country	Name	City	State
India	Research Site	Lucknow
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Petaling Jaya
Philippines	Research Site	Davao City
Philippines	Research Site	Mandaluyong City
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
Poland	Research Site	Poznan
Poland	Research Site	Torun
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Serbia	Research Site	Belgrade
Serbia	Research Site	Novi Sad
South Africa	Research Site	Pretoria
Ukraine	Research Site	Kharkov
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
United States	Research Site	Altamonte Springs	Florida
United States	Research Site	Austin	Texas
United States	Research Site	Bellevue	Washington
United States	Research Site	Cerritos	California
United States	Research Site	Chicago	Illinois
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cleveland	Ohio
United States	Research Site	Denver	Colorado
United States	Research Site	Dothan	Alabama
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Kirkland	Washington
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Lyndhurst	Ohio
United States	Research Site	Memphis	Tennessee
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Newton	Kansas
United States	Research Site	Oak Brook	Illinois
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Overland Park	Kansas
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Richmond	Virginia
United States	Research Site	Riverside	California
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  India,  Malaysia,  Philippines,  Poland,  Russian Federation,  Serbia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Nature of Adverse Events (AEs)	Number of participants that had AE which occurred from first dose date to last dose date + 30 days.	from open label to week 26+ 30 days	Yes
Primary	Number of Patients Withdrawn Due to AEs.	Number of subjects who withdrew from the study due to AEs.	during 26 weeks of treatment	Yes
Primary	Changes in Laboratory Test Results (Prolactin)	Clinical important shift to high prolactin from open-label (OL) baseline to week 26.; High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male.	Duration of study participation	Yes
Primary	Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score	Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).; Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score.	OL baseline to week 26	Yes
Primary	Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score	Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.; Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score.	26 weeks of treatment	Yes
Primary	Change From Baseline in Weight	Number with 7% or more increase (without adjustment for normal growth)	26 weeks of treatment	Yes
Primary	Change From Baseline in Supine Pulse	Change from OL baseline to week 26 in supine pulse (bpm)	OL baseline to week 26	Yes
Primary	Change From OL Baseline in Supine Systolic BP.	Changes from OL baseline to the final visits in Supine systolic BP (mmHg)	OL baseline to Week 26	Yes
Primary	Change From OL Baseline in Supine Diastolic BP.	Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)	OL baseline to Week 26	Yes
Secondary	Changes in Tanner Stage	Category shift in Tanner stage. Number of subjects who experienced the change is presented.; Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger.	Change from OL baseline to week 26 in the Tanner stage	Yes
Secondary	Change From Baseline in Children's Global Assessment Scale (CGAS) Score	Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal).	OL Baseline to Week 26	No