NCT00227305

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
381

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3 schizophrenia

Geographic Reach
9 countries

48 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2012

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

September 27, 2005

Results QC Date

December 22, 2008

Last Update Submit

January 3, 2013

Conditions

SchizophreniaBipolar I Disorder

Keywords

SchizophreniaBipolar I Disorder

Outcome Measures

Primary Outcomes (9)

  • 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

  • Number of Patients Withdrawn Due to AEs.

    Number of subjects who withdrew from the study due to AEs.

    during 26 weeks of treatment

  • 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

  • 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

  • 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

  • Change From Baseline in Weight

    Number with 7% or more increase (without adjustment for normal growth)

    26 weeks of treatment

  • Change From Baseline in Supine Pulse

    Change from OL baseline to week 26 in supine pulse (bpm)

    OL baseline to week 26

  • 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

  • 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

Secondary Outcomes (2)

  • Changes in Tanner Stage

    Change from OL baseline to week 26 in the Tanner stage

  • Change From Baseline in Children's Global Assessment Scale (CGAS) Score

    OL Baseline to Week 26

Interventions

quetiapine fumarateDRUG

Oral dosing, flexible dosing

Also known as: Seroquel

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

Research Site

Dothan, Alabama, United States

Location

Research Site

Scottsdale, Arizona, United States

Location

Research Site

Cerritos, California, United States

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Research Site

Riverside, California, United States

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Research Site

Sacramento, California, United States

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San Diego, California, United States

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Denver, Colorado, United States

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Altamonte Springs, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Chicago, Illinois, United States

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Oak Brook, Illinois, United States

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Newton, Kansas, United States

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Overland Park, Kansas, United States

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New Orleans, Louisiana, United States

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Las Vegas, Nevada, United States

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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Research Site

Cleveland, Ohio, United States

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Lyndhurst, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Bellevue, Washington, United States

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Kirkland, Washington, United States

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Milwaukee, Wisconsin, United States

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Lucknow, India

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Kuala Lumpur, Malaysia

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Petaling Jaya, Malaysia

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Davao City, Philippines

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Mandaluyong, Philippines

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Manila, Philippines

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Quezon City, Philippines

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Poznan, Poland

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Torun, Poland

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Moscow, Russia

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Saint Petersburg, Russia

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Belgrade, Serbia

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Novi Sad, Serbia

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Pretoria, South Africa

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Kharkiv, Ukraine

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Lviv, Ukraine

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Research Site

Odesa, Ukraine

Location

Related Publications (1)

  • 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.

    PMID: 24024534DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

No comparator group, open label treatment, duration only 26 weeks - not long enough to assess full impact on growth and development

Results Point of Contact

Title
Seroquel Medical Science Director, MD
Organization
AstraZeneca
AZTrial_Results_Posting@astrazeneca.com

Study Officials

  • Seroquel Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

August 1, 2004

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 8, 2013

Results First Posted

October 5, 2012

Record last verified: 2013-01

Locations

UA(3)ZA(1)RU(2)US(31)SE(2)PH(4)MY(2)PL(2)IN(1)