NCT00227305

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	quetiapine fumarate	Oral dosing, flexible dosing

Timeline

• Start date: 2004-08-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-28
• Last updated: 2013-01-08
• Results posted: 2012-10-05

Locations

48 sites across 9 countries: United States, India, Malaysia, Philippines, Poland, Russia, Serbia, South Africa, Ukraine