Study identifier:D1443L00055
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination with Lithium in the Treatment of Patients with Acute Bipolar Depression
Acute bipolar depression
Phase 3
No
Quetiapine fumarate XR, Lithium carbonate
All
421
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Quetiapin fumarate XR Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. | Drug: Quetiapine fumarate XR Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Other Name: SEROQUEL XR |
Experimental: Quetiapin fumarate XR+Lithium carbonate Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56. | Drug: Quetiapine fumarate XR Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Other Name: SEROQUEL XR Drug: Lithium carbonate Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day Other Name: LITHURIL Tb in TURKEY Other Name: LITOCARB in PERU |