Adult Bipolar Mania
Study identifier:D144AC00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium versus Placebo as an add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients with Acute Mania
Medical condition
Acute Mania
Phase
Phase 4
Healthy volunteers
No
Study drug
Quetiapine fumarate XR, Lithium, Placebo
Sex
All
Actual Enrollment
356
Study type
Interventional
Age
18 Years - 65 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Quintiles Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Seroquel XR and Lithium | Drug: Quetiapine fumarate XR Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator. Other Name: Seroquel XR Drug: Lithium Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator. |
| Placebo Comparator: 2 Seroquel XR and placebo | Drug: Quetiapine fumarate XR Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator. Other Name: Seroquel XR Drug: Placebo Oral treatment twice daily. |
Contacts
Investigators
Principal Investigator
Michael Castiglione
AstraZeneca Pharmaceuticals
