Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders - Full Text View

Purpose

The purpose of this study is to evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in patients with MDD with inadequate response to an antidepressant treatment.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Quetiapine fumarate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Formic acid Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate the efficacy of quetiapine SR in combination with an antidepressant versus an antidepressant alone in MDD patients with inadequate response to an antidepressant treatment as assessed by the change from randomization to week 6 in the MADRS

Secondary Outcome Measures:

To evaluate if quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone
To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone

Estimated Enrollment:	450
Study Start Date:	April 2006
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326105

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Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, California
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El Centro, California, United States
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Irvine, California, United States
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Oceanside, California, United States
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San Diego, California, United States
United States, Colorado
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Pueblo, Colorado, United States
United States, Florida
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Coral Springs, Florida, United States
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Deland, Florida, United States
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Gainsville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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West Palm Beach, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
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Roswell, Georgia, United States
United States, Illinois
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Hoffman Estates, Illinois, United States
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Naperville, Illinois, United States
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Oak Brook, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Valparaiso, Indiana, United States
United States, Kansas
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
United States, Louisiana
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Shreveport, Louisiana, United States
United States, Maryland
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Glen Burnie, Maryland, United States
United States, Massachusetts
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Braintree, Massachusetts, United States
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Springfield, Massachusetts, United States
United States, Michigan
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Clinton Township, Michigan, United States
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Kalamazoo, Michigan, United States
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Royal Oak, Michigan, United States
United States, Missouri
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St Charles, Missouri, United States
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St. Louis, Missouri, United States
United States, New Jersey
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Cherry Hill, New Jersey, United States
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Clementon, New Jersey, United States
United States, New York
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Cedarhurst, New York, United States
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New York, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
United States, Ohio
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Beechwood, Ohio, United States
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Toledo, Ohio, United States
United States, Oklahoma
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States
United States, Rhode Island
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Lincoln, Rhode Island, United States
United States, South Carolina
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Columbia, South Carolina, United States
United States, Tennessee
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Memphis, Tennessee, United States
United States, Texas
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Friendswood, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
United States, Utah
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Salt Lake City, Utah, United States
United States, Virginia
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Arlington, Virginia, United States
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Richmond, Virginia, United States
United States, Washington
Research Site
Bellevue, Washington, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

El-Khalili N, Joyce M, Atkinson S, Buynak RJ, Datto C, Lindgren P, Eriksson H. Extended-release quetiapine fumarate (quetiapine XR) as adjunctive therapy in major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant treatment: a multicentre, randomized, double-blind, placebo-controlled study. Int J Neuropsychopharmacol. 2010 Aug;13(7):917-32. Epub 2010 Feb 23.

ClinicalTrials.gov Identifier:	NCT00326105 History of Changes
Other Study ID Numbers:	D1448C00006, PEARL
Study First Received:	May 15, 2006
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

MDD
Depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Quetiapine

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013

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