Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: quetiapine fumarate tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.

Official title: A 6-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-Release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42

Secondary outcome: Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is able to provide written assent and the parents or legal guardian of the

patient is able to provide written informed consent before beginning and study related procedures

- Patient has a documented clinical diagnosis of schizophrenia

- Patient's parent or legal guardian will be able to accompany the patient at 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

Research Site, AACHEN, Germany

Research Site, KANPUR, India

Research Site, LUCKNOW, India

Research Site, KUALA LUMPUR, Malaysia

Research Site, PETALING JAYA, Malaysia

Research Site, DAVAO CITY, Philippines

Research Site, MANDALUYONG CITY, Philippines

Research Site, MANILA, Philippines

Research Site, QUEZON CITY, Philippines

Research Site, POZNAN, Poland

Research Site, TORUN, Poland

Research Site, MOSCOW, Russian Federation

Research Site, ST. PETERSBURG, Russian Federation

Research Site, BELGRADE, Serbia and Montenegro

Research Site, NOVI SAD, Serbia and Montenegro

Research Site, PRETORIA, South Africa

Research Site, KHARKOV, Ukraine

Research Site, KIEV, Ukraine

Research Site, ODESSA, Ukraine

Research Site, DOTHAN, Alabama, United States

Research Site, Riverside, California, United States

Research Site, Sacramento, California, United States

Research Site, San Diego, California, United States

Research Site, CERRITOS, California, United States

Research Site, Denver, Colorado, United States

Research Site, Alamonte, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Miami, Florida, United States

Research Site, Chicago, Illinois, United States

Research Site, Oak Brook, Illinois, United States

Research Site, NEWTON, Kansas, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Las Vegas, Nevada, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Cleveland, Ohio, United States

Research Site, Lyndhurst, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Memphis, Tennessee, United States

Research Site, Richmond, Virginia, United States

Research Site, Virginia Beach, Virginia, United States

Research Site, Kirkland, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

AstraZeneca Clinical Trial Information - Outside US

Starting date: July 2004
Ending date: August 2007
Last updated: November 2, 2007