Study of the Broad Clinical Benefit for Seroquel XR with flexible dose as an add-on therapy in the Treatment of Acute Bipolar Mania patients with Partial Response to Current Therapy - RELEASE
Study identifier:D1443L00080
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate extended release) with flexible dose as an add-on therapy in the Treatment of Acute Bipolar Mania patients with Partial Response to Current Therapy
Medical condition
Acute bipolar mania
Phase
Phase 4
Healthy volunteers
No
Study drug
Quetiapine fumarate (Seroquel XR)
Sex
All
Actual Enrollment
32
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Mar 2011
Study Completion Date: 01 Mar 2011
Study design
Allocation: None
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Quetiapine XR Quetiapine fumarate (Seroquel XR) | Drug: Quetiapine fumarate (Seroquel XR) Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study. Other Name: Seroquel XR tablet |
Contacts
Investigators
Principal Investigator
Joon Woo Bahn
AstraZeneca
