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

January 3, 2013 updated by: AstraZeneca

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

381

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and Nature of Adverse Events (AEs)
Time Frame: from open label to week 26+ 30 days
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
Number of Patients Withdrawn Due to AEs.
Time Frame: during 26 weeks of treatment
Number of subjects who withdrew from the study due to AEs.
during 26 weeks of treatment
Changes in Laboratory Test Results (Prolactin)
Time Frame: Duration of study participation

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
Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
Time Frame: OL baseline to week 26

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
Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
Time Frame: 26 weeks of treatment

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
Change From Baseline in Weight
Time Frame: 26 weeks of treatment
Number with 7% or more increase (without adjustment for normal growth)
26 weeks of treatment
Change From Baseline in Supine Pulse
Time Frame: OL baseline to week 26
Change from OL baseline to week 26 in supine pulse (bpm)
OL baseline to week 26
Change From OL Baseline in Supine Systolic BP.
Time Frame: OL baseline to Week 26
Changes from OL baseline to the final visits in Supine systolic BP (mmHg)
OL baseline to Week 26
Change From OL Baseline in Supine Diastolic BP.
Time Frame: OL baseline to Week 26
Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
OL baseline to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Tanner Stage
Time Frame: Change from OL baseline to week 26 in the 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
Change From Baseline in Children's Global Assessment Scale (CGAS) Score
Time Frame: OL Baseline to Week 26
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

January 3, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1441C00150

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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