Pediatric Bipolar Depression
Study identifier:D144AC00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
bipolar depression
Phase
Phase 3
Healthy volunteers
No
Study drug
Quetiapine XR, Placebo
Sex
All
Actual Enrollment
193
Study type
Interventional
Age
10 Years - 17 Years
Date
Study Start Date: 01 Jan 2009
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Quetiapine XR | Drug: Quetiapine XR Oral treatment with 150 up to 300 mg/day once daily in the evening Other Name: Seroquel XR |
| Placebo Comparator: Placebo | Drug: Placebo Oral treatment once daily in the evening |
Contacts
Investigators
Principal Investigator
Michael Castiglione
AstraZeneca Pharmaceuticals
