Study identifier:D144CC00005
ClinicalTrials.gov identifier:NCT01256177
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients with Bipolar Depression
bipolar depression
Phase 3
No
Quetiapine Fumarate (SEROQUEL) Extended Release, Placebo
All
361
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Mar 2016 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 | Drug: Quetiapine Fumarate (SEROQUEL) Extended Release Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after. |
Placebo Comparator: 2 | Drug: Placebo Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after. |