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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00227305
• Date of registration: 27/09/2005
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder ANCHOR 150
• Scientific 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)
• Date of first enrolment: August 2004
• Target sample size: 381
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00227305
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Former Serbia and Montenegro, India, Malaysia, Philippines, Poland, Russian Federation, Serbia, South Africa, Ukraine, United States

Contacts

• Name: Seroquel Medical Science Director, MD
• Affiliation: AstraZeneca

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Bipolar I Disorder

Schizophrenia

Intervention(s)

Drug: quetiapine fumarate

Primary Outcome(s)

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

Change From Baseline in Supine Pulse [Time Frame: OL baseline to week 26]

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

Change From OL Baseline in Supine Systolic BP. [Time Frame: OL baseline to Week 26]

Change From OL Baseline in Supine Diastolic BP. [Time Frame: OL baseline to Week 26]

Changes in Laboratory Test Results (Prolactin) [Time Frame: Duration of study participation]

Number of Patients Withdrawn Due to AEs. [Time Frame: during 26 weeks of treatment]

Incidence and Nature of Adverse Events (AEs) [Time Frame: from open label to week 26+ 30 days]

Change From Baseline in Weight [Time Frame: 26 weeks of treatment]

Secondary Outcome(s)

Change From Baseline in Children's Global Assessment Scale (CGAS) Score [Time Frame: OL Baseline to Week 26]

Changes in Tanner Stage [Time Frame: Change from OL baseline to week 26 in the Tanner stage]

Secondary ID(s)

D1441C00150

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00227305