Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination with an Antidepressant in the Treatment of Major Depressive Disorders - PEARL

Study identifier:D1448C00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination with an Antidepressant in the Treatment of Patients with Major Depressive Disorder with Inadequate Response to an Antidepressant Treatment (PEARL STUDY)

Medical condition

Major depressive disorder

Phase

Phase 3

Healthy volunteers

No

Study drug

Quetiapine fumarate

Sex

All

Actual Enrollment

450

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Apr 2006
Primary Completion Date: -
Study Completion Date: 01 Jul 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 Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria