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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00326105

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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: 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

Show 56 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

More Information

No publications provided

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

Keywords provided by AstraZeneca:

MDD
Depression

Additional relevant MeSH terms:

Tranquilizing Agents
Depression
Disease
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Antipsychotic Agents
Depressive Disorder

Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010