Efficacy and Safety of Seroquel plus mood stabilizer in the maintenance of Bipolar I disorder
Study identifier:D1447C00127
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Multicenter, Randomized, Parallel-group, Double-blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients (abbreviated)
Medical condition
Bipolar Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
Seroquel®, quetiapine fumarate (atypical antipsychotic), lithium (mood stabilizer), divalproex (mood stabilizer)
Sex
All
Actual Enrollment
710
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Mar 2004
Primary Completion Date: -
Study Completion Date: 01 Sept 2006
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
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Contacts
Investigators
Principal Investigator
AstraZeneca Seroquel Medical Science Director
AstraZeneca
