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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: Quetiapine fumarate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

Summary

The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the treatment of Major Depressive Disorders PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Clinical Details

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 SRŪ) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: To evaluate the efficacy of Quetiapine SR compared with placebo in the treatment of patients with MDD as assessed by change from randomization to Week 8 in the MADRS total score

Secondary outcome:

To evaluate if Quetiapine SR improves the health-related quality of life of patients with MDD, compared to placebo

To evaluate if quetiapine SR reduces anxiety symptoms in patients with MDD, compared to placebo

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is able to provide written informed consent before beginning any study

related procedures

- Patient has a documented clinical diagnosis of major depressive disorder

- Patient is able to understand and comply with the requirements of the study, as

judged by a study investigator Exclusion Criteria:

- Patients with a history of non-compliance as judged by the study investigator

- Patients with a known lack of response to previous treatment with quetiapine

- Patients who have participated in a clinical trial within 4 weeks of randomization

Locations and Contacts

Research Site, Phoenix, Arizona, United States

Research Site, Little Rock, Arkansas, United States

Research Site, Anaheim, California, United States

Research Site, El Centro, California, United States

Research Site, Garden Grove, California, United States

Research Site, National City, California, United States

Research Site, Riverside, California, United States

Research Site, Hartford, Connecticut, United States

Research Site, Wilmington, Delaware, United States

Research Site, Altamonte Springs, Florida, United States

Research Site, DeLand, Florida, United States

Research Site, Maitland, Florida, United States

Research Site, New Port Richey, Florida, United States

Research Site, Atlanta, Georgia, United States

Research Site, Decatur, Georgia, United States

Research Site, Roswell, Georgia, United States

Research Site, Naperville, Illinois, United States

Research Site, Indianapolis, Indiana, United States

Research Site, Lafayette, Indiana, United States

Research Site, Owensboro, Kentucky, United States

Research Site, New Orleans, Louisiana, United States

Research Site, Braintree, Massachusetts, United States

Research Site, Cambridge, Massachusetts, United States

Research Site, Pittsfield, Massachusetts, United States

Research Site, Minneapolis, Minnesota, United States

Research Site, St. Louis, Missouri, United States

Research SIte, Staten Island, New York, United States

Research Site, Avon Lake, Ohio, United States

Research Site, Cincinnati, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, Memphis, Tennessee, United States

Research Site, DeSoto, Texas, United States

Research Site, Houston, Texas, United States

Additional Information

Starting date: April 2006
Last updated: March 24, 2009

Page last updated: August 23, 2015

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