Study identifier:D1447C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks & Quetiapine in Continuation (abbreviated)
Bipolar Disorder
Phase 3
No
Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
All
672
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2013 by AstraZeneca
AstraZeneca
-
This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.
Location
Location
Lawang, Indonesia
Location
Seoul, Republic of Korea
Location
Gyeonggi-do, Republic of Korea
Location
Kuala Lumpur, Malaysia
Location
Petaling Jaya, Malaysia
Location
Kuching Sarawak, Malaysia
Location
Mysen, Norway
Location
Paradis, Norway
Arms | Assigned Interventions |
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