Pediatric Bipolar Depression

Condition(s) targeted: Bipolar Depression

Intervention: quetiapine XR (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Vince Mazzella, Study Director, Affiliation: AstraZeneca
Robert L. Findling, Principal Investigator, Affiliation: University Hospitals Case Medical CenterCase Western Reserve University School of Medicine

Overall contact:
Ingalill Reinholdsson, Phone: +46 8 553 26448, Email: ingalill.reinholdsson@astrazeneca.com

The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).

Official title: An 8-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Change in the CDRS-R total score from baseline to final assessment (Day 57)

Secondary outcome:

Changes in CDRS-R scores in reduction, remission and change in total score

Changes in CGI-BP-S and CGI-BP-C score

Incidence of AE's, including extrapyramidal symptoms (EPS) and other specific safety areas, including somnolence, suicidality, neutropenia/agranulocytosis and thyroid function

Minimum age: 10 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Provision of informed consent by one or both parents or legal guardian and written

assent by the patients before any study procedures are performed.

- The patient must have a documented clinical diagnosis for bipolar I or bipolar II

disorder, and including current episode depressed.

- Patients are required to be in outpatient status at the enrollment and randomization

visits and believed likely to remain an outpatient for the duration of the study.

- Patients must be able to swallow the study medication tablets.

Exclusion Criteria:

- The patient must not have been diagnosed with Tourette's Disorder,

Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.

- Patient can not have a history of non-response to an adequate treatment to more than 2

antidepressants during the current episode.

- The patient must not have received electroconvulsive therapy (ECT) within 30 days

before participating in the study.

- Patients who in your doctors judgement pose a current suicidal or homicidal risk.

Ingalill Reinholdsson, Phone: +46 8 553 26448, Email: ingalill.reinholdsson@astrazeneca.com

Research Site, DOTHAN, Alabama, United States; Not yet recruiting

Research Site, SCOTTSDALE, Arizona, United States; Not yet recruiting

Research Site, LITTLE ROCK, Arkansas, United States; Not yet recruiting

Research Site, ALAMONTE SPRINGS, Florida, United States; Not yet recruiting

Research Site, GAINSVILLE, Florida, United States; Not yet recruiting

Research Site, JACKSONVILLE, Florida, United States; Not yet recruiting

Research Site, MAITLAND, Florida, United States; Not yet recruiting

Research Site, NORTH MIAMI, Florida, United States; Not yet recruiting

Research Site, TAMPA, Florida, United States; Not yet recruiting

Research Site, ATLANTA, Georgia, United States; Not yet recruiting

Research Site, SMYRNA, Georgia, United States; Not yet recruiting

Research Site, EAGLE, Idaho, United States; Not yet recruiting

Research Site, HOFFMAN ESTATES, Illinois, United States; Not yet recruiting

Research Site, TERRE HAUTE, Indiana, United States; Not yet recruiting

Research Site, NEWTON, Kansas, United States; Not yet recruiting

Research Site, OVERLAND PARK, Kansas, United States; Not yet recruiting

Research Site, CLINTON TOWNSHIP, Michigan, United States; Not yet recruiting

Research Site, MINNEAPOLIS, Minnesota, United States; Not yet recruiting

Research Site, ST. LOUIS, Missouri, United States; Not yet recruiting

Research Site, LINCOLN, Nebraska, United States; Not yet recruiting

Research Site, ROCHESTER, New York, United States; Recruiting

Research Site, CINCINNATI, Ohio, United States; Not yet recruiting

Research Site, CLEVELAND, Ohio, United States; Not yet recruiting

Research Site, OKLAHOMA CITY, Oklahoma, United States; Not yet recruiting

Research Site, CHARLESTON, South Carolina, United States; Not yet recruiting

Research Site, MEMPHIS, Tennessee, United States; Not yet recruiting

Research Site, AUSTIN, Texas, United States; Not yet recruiting

Research Site, HOUSTON, Texas, United States; Not yet recruiting

Research Site, WHARTON, Texas, United States; Not yet recruiting

Research Site, VIRGINIA BEACH, Virginia, United States; Not yet recruiting

Research Site, BOTHELL, Washington, United States; Not yet recruiting

Starting date: January 2009
Ending date: April 2011
Last updated: January 30, 2009