Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients with Bipolar Depression

Study identifier:D144CC00005

ClinicalTrials.gov identifier:NCT01256177

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients with Bipolar Depression

Medical condition

bipolar depression

Phase

Phase 3

Healthy volunteers

No

Study drug

Quetiapine Fumarate (SEROQUEL) Extended Release, Placebo

Sex

All

Actual Enrollment

361

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Dec 2010
Primary Completion Date: 01 Nov 2012
Study Completion Date: 01 Nov 2012

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria