Efficacy and safety of quetiapine versus quetiapine plus lithium in bipolar depression - QUALITY
Study identifier:D1443L00055
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Acute bipolar depression
Phase
Phase 3
Healthy volunteers
No
Study drug
Quetiapine fumarate XR, Lithium carbonate
Sex
All
Actual Enrollment
421
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Apr 2009
Primary Completion Date: 01 Mar 2011
Study Completion Date: 01 Mar 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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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 |
Contacts
Investigators
Principal Investigator
Simavi Vahip
Ege University Faculty of Medicine Psychiatry Department İzmir
