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