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

Phase 3

Completed

• Conditions: Schizophrenia; Bipolar I Disorder

• Registration Number: NCT00227305
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-28
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-22
• Results First Submitted QC: 2012-09-05
• Results First Posted: 2012-10-05
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-03
• Last Update Posted: 2013-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence and Nature of Adverse Events (AEs)	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.
Number of Patients Withdrawn Due to AEs.	during 26 weeks of treatment	Number of subjects who withdrew from the study due to AEs.
Change From Baseline in Weight	26 weeks of treatment	Number with 7% or more increase (without adjustment for normal growth)
Change From Baseline in Supine Pulse	OL baseline to week 26	Change from OL baseline to week 26 in supine pulse (bpm)
Change From OL Baseline in Supine Diastolic BP.	OL baseline to Week 26	Changes from OL baseline to the final visits in Supine diastolic BP (mmHg)
Changes in Laboratory Test Results (Prolactin)	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.
Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score	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.
Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score	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.
Change From OL Baseline in Supine Systolic BP.	OL baseline to Week 26	Changes from OL baseline to the final visits in Supine systolic BP (mmHg)

Secondary Outcome Measures

Name	Time	Method
Changes in Tanner Stage	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 Baseline in Children's Global Assessment Scale (CGAS) Score	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).

Trial Locations

Locations (1)

Research Site; 🇺🇦 Odessa, Ukraine