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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)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00326105
First received: May 15, 2006
Last updated: March 24, 2009
Last verified: March 2009
History of Changes

May 15, 2006
March 24, 2009
April 2006
Not Provided
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
Same as current
Complete list of historical versions of study NCT00326105 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in Combination With an Antidepressant in the Treatment of Major Depressive Disorders
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)

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Quetiapine fumarate
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
July 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00326105
D1448C00006, PEARL
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP