Efficacy & Safety of Seroquel plus mood stabilizer in the maintenance of Bipolar I disorder
Study identifier:D1447C00126
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Parallel-group, Double-blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (Abbreviated)
Medical condition
Bipolar I Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
quetiapine fumarate, lithium, divalproex
Sex
All
Actual Enrollment
710
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Apr 2004
Primary Completion Date: -
Study Completion Date: 01 Oct 2006
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
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
