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Pediatric Bipolar Depression | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT00811473

Pediatric Bipolar Depression

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 adoles...

Lead sponsor: AstraZeneca•31 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

AstraZeneca

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 15, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment193

Start dateJan 2009

Last updatedJul 15, 2014

Condition

Bipolar Depression

Locations shown

Research Site

Dothan, Alabama

Research Site

Scottsdale, Arizona

Research Site

Little Rock, Arkansas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 15, 2014Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions