Study identifier:D1448C00006
ClinicalTrials.gov identifier:NCT00326105
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Major depressive disorder
Phase 3
No
Quetiapine fumarate
All
450
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
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.
Location
Location
Phoenix, AZ, United States
Location
El Centro, CA, United States
Location
Oceanside, CA, United States
Location
Pueblo, CO, United States
Location
Hialeah, FL, United States
Location
West Palm Beach, FL, United States
Location
Indianapolis, IN, United States
Location
Lafayette, IN, United States
Arms | Assigned Interventions |
---|
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.