Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder

Phase 3CompletedNCT00320268

AstraZeneca600 enrolled

Overview

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Major Depressive Disorder

Interventions

Quetiapine fumarateDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has a documented clinical diagnosis of Major Depressive Disorder. * Be able to understand and comply with the requirements of the study. * Able to understand and provide written informed consent Exclusion Criteria: * Patients (female) must not be pregnant or lactating * Current or past diagnosis of stroke or transient ischemic attack (TIA).

Locations (37)

Outcomes

Primary Outcomes

Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary Outcomes

Change from randomization to each assessment in the MADRS total score

MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

Data from ClinicalTrials.gov

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Research Site

Little Rock, Arkansas, United States

Research Site

Newport Beach, California, United States

Research Site

Northridge, California, United States

Research Site

Oceanside, California, United States

Research Site

Santa Ana, California, United States

Research Site

Denver, Colorado, United States

Research Site

Norwich, Connecticut, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Jacksonville, Florida, United States

Research Site

Winter Park, Florida, United States

...and 27 more locations