Study identifier:D1443C00040
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) with Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalation in Patients with Bipolar Depression
bipolar depression
Phase 4
No
Quetiapine Immediate Release, Quetiapine Extended Release
All
139
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verified 01 May 2011 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Quetiapine Immediate Release (IR) Quetiapine 25, 100, 200 and 300 mg | Drug: Quetiapine Immediate Release Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day Other Name: Seroquel IR |
Active Comparator: Quetiapine Extended Release (XR) Quetiapine 50, 200, 300 | Drug: Quetiapine Extended Release Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day Other Name: Seroquel XR |