Seroquel in Bipolar Depression versus SSRI - EMBOLDEN II
Study identifier:D1447C00134
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Multicentre, double-blind, randomised, parallel group, placebo controlled, phase 3 study of the efficacy & safety of quetiapine fumarate & paroxetine as monotherapy in adult patients with bipolar depression for 8 weeks & quetiapine in continuation (Abbreviated)
Medical condition
Bipolar Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
quetiapine fumarate (Seroquel), paroxetine
Sex
All
Actual Enrollment
676
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 May 2005
Primary Completion Date: -
Study Completion Date: 01 May 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
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Contacts
Investigators
Principal Investigator
AstraZeneca Seroquel Medical Science Director
AstraZeneca
