Status:
COMPLETED
Pediatric Bipolar Depression
Lead Sponsor:
AstraZeneca
Conditions:
Bipolar Depression
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT00811473
Start Date
January 1 2009
End Date
November 1 2010
Last Update
July 15 2014
Active Locations (48)
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1
Research Site
Dothan, Alabama, United States
2
Research Site
Scottsdale, Arizona, United States
3
Research Site
Little Rock, Arkansas, United States
4
Research Site
Escondido, California, United States