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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00326105
Recruitment Status : Completed
First Posted : May 16, 2006
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:

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 or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Quetiapine fumarate Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : April 2006
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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
  2. To evaluate if quetiapine SR in combination with an antidepressant reduces anxiety symptoms in patients with MDD, compared to an antidepressant alone


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326105


  Show 56 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Seroquel Medical Science Director, MD AstraZeneca

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

ClinicalTrials.gov Identifier: NCT00326105     History of Changes
Other Study ID Numbers: D1448C00006
PEARL
First Posted: May 16, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
MDD
Depression

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Quetiapine Fumarate
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs