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Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder (ANCHOR 150)

Primary Purpose

Schizophrenia, Bipolar I Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
quetiapine fumarate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Bipolar I Disorder

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

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.
Number of Patients Withdrawn Due to AEs.
Number of subjects who withdrew from the study due to AEs.
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.
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.
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.
Change From Baseline in Weight
Number with 7% or more increase (without adjustment for normal growth)
Change From Baseline in Supine Pulse
Change from OL baseline to week 26 in supine pulse (bpm)
Change From OL Baseline in Supine Systolic BP.
Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
Change From OL Baseline in Supine Diastolic BP.
Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)

Secondary Outcome Measures

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 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).

Full Information

First Posted
September 27, 2005
Last Updated
January 3, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00227305
Brief Title
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar I Disorder
Keywords
Schizophrenia, Bipolar I Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate
Other Intervention Name(s)
Seroquel
Intervention Description
Oral dosing, flexible dosing
Primary Outcome Measure Information:
Title
Incidence and Nature of Adverse Events (AEs)
Description
Number of participants that had AE which occurred from first dose date to last dose date + 30 days.
Time Frame
from open label to week 26+ 30 days
Title
Number of Patients Withdrawn Due to AEs.
Description
Number of subjects who withdrew from the study due to AEs.
Time Frame
during 26 weeks of treatment
Title
Changes in Laboratory Test Results (Prolactin)
Description
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.
Time Frame
Duration of study participation
Title
Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
Description
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.
Time Frame
OL baseline to week 26
Title
Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
Description
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.
Time Frame
26 weeks of treatment
Title
Change From Baseline in Weight
Description
Number with 7% or more increase (without adjustment for normal growth)
Time Frame
26 weeks of treatment
Title
Change From Baseline in Supine Pulse
Description
Change from OL baseline to week 26 in supine pulse (bpm)
Time Frame
OL baseline to week 26
Title
Change From OL Baseline in Supine Systolic BP.
Description
Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
Time Frame
OL baseline to Week 26
Title
Change From OL Baseline in Supine Diastolic BP.
Description
Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
Time Frame
OL baseline to Week 26
Secondary Outcome Measure Information:
Title
Changes in Tanner Stage
Description
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.
Time Frame
Change from OL baseline to week 26 in the Tanner stage
Title
Change From Baseline in Children's Global Assessment Scale (CGAS) Score
Description
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).
Time Frame
OL Baseline to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seroquel Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Dothan
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Cerritos
State/Province
California
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Research Site
City
Altamonte Springs
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Oak Brook
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
Newton
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
Overland Park
State/Province
Kansas
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Lyndhurst
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Kirkland
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Research Site
City
Lucknow
Country
India
Facility Name
Research Site
City
Kuala Lumpur
Country
Malaysia
Facility Name
Research Site
City
Petaling Jaya
Country
Malaysia
Facility Name
Research Site
City
Davao City
Country
Philippines
Facility Name
Research Site
City
Mandaluyong City
Country
Philippines
Facility Name
Research Site
City
Manila
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Novi Sad
Country
Serbia
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Kharkov
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
24024534
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.
Results Reference
derived

Learn more about this trial

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

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