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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder; Schizophrenia

Treatments: Drug: quetiapine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00227305

D1441C00150

Details and patient eligibility

About

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.

Enrollment: 381 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)