Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders - OPAL

Study identifier:D1448C00003

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 SR®) as Mono-Therapy in the Treatment of Adult Patients with Major Depressive Disorder

Medical condition

Major depressive disorder

Phase

Phase 3

Healthy volunteers

No

Study drug

Quetiapine fumarate

Sex

All

Actual Enrollment

310

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Apr 2006
Primary Completion Date: -
Study Completion Date: 01 May 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