A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative,study - STAR
Study identifier:D1443L00086
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study
Medical condition
Acute bipolar mania
Phase
Phase 4
Healthy volunteers
No
Study drug
Quetiapine fumarate, lithium
Sex
All
Actual Enrollment
131
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Dec 2010
Primary Completion Date: 01 Oct 2012
Study Completion Date: 01 Oct 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Seroquel XR tablet | Drug: Quetiapine fumarate eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study. |
| Active Comparator: 2 Seroquel XR + lithium | Drug: Quetiapine fumarate eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study. Drug: lithium 300mg tablet, oral |
Contacts
Investigators
Principal Investigator
Yeon Ho Joo
Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
