Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) in the treatment of alcohol dependency in patients with bipolar disorder
Study identifier:D144AL00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) versus Placebo as Adjunct Therapy with Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients with Bipolar I Disorder
Medical condition
Bipolar I Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
Quetiapine fumarate, lithium, divalproex
Sex
All
Actual Enrollment
350
Study type
Interventional
Age
21 Years - 60 Years
Date
Study Start Date: 01 Jan 2006
Primary Completion Date: -
Study Completion Date: 01 Apr 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
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Contacts
Investigators
Principal Investigator
AstraZeneca Seroquel Medical Science Director
AstraZeneca
