Pediatric Bipolar Depression

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

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).

Key facts

Study ID

NCT00811473

Run by

AstraZeneca

People needed

193

Starts

2009-01-01

Expected to finish

2010-11-01

Last updated by the study team

2014-07-15

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Dothan, Alabama, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Escondido, California, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Gainsville, Florida, United States
• Research Site — North Miami, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Smyrna, Georgia, United States
• Research Site — Eagle, Idaho, United States
• Research Site — Hoffman Estates, Illinois, United States
• Research Site — Terre Haute, Indiana, United States
• Research Site — Overland Park, Kansas, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Clinton Township, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Flowood, Mississippi, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Lincoln, Nebraska, United States
• Research Site — Rochester, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Mason, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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