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
-
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.
Location
Location
LA PLATA, Buenos Aires, Argentina
Location
GODOY CRUZ, Mendoza, Argentina
Location
MENDOZA, Mendoza, Argentina
Location
CABA, Argentina
Location
APARECIDA DE GOIANIA, GO, Brazil
Location
RIO DE JANEIRO, RIO DE JANEIRO, Brazil
Location
SAO PAULO, SP, Brazil
Location
SANTIAGO, CHILE, Chile
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 |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.