Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00227305
Other study ID # D1441C00150
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A