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