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