Quetiapine Fumarate Bipolar Maintenance Monotherapy - SPaRCLe
Study identifier:D1447C00144
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
Medical condition
Bipolar Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
quetiapine fumarate
Sex
All
Actual Enrollment
1255
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Mar 2005
Primary Completion Date: -
Study Completion Date: 01 Jul 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
Loading...
No locations available
| Arms | Assigned Interventions |
|---|
Contacts
Investigators
Principal Investigator
AstraZeneca CNS Medical Science Director
AstraZeneca
