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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00326105

Public ClinicalTrials.gov record NCT00326105. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 10:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00326105
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
AstraZeneca
Industry
Enrollment
450 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2006
Primary completion
Not listed
Completion
Jun 30, 2007
Last update posted
Mar 24, 2009

2006 – 2007

United States locations

U.S. sites
56
U.S. states
25
U.S. cities
56
Facility City State ZIP Site status
Research Site Phoenix Arizona
Research Site El Centro California
Research Site Irvine California
Research Site Oceanside California
Research Site San Diego California
Research Site Pueblo Colorado
Research Site Coral Springs Florida
Research Site DeLand Florida
Research Site Gainsville Florida
Research Site Hialeah Florida
Research Site Jacksonville Florida
Research Site Miami Florida
Research Site Orlando Florida
Research Site West Palm Beach Florida
Research Site Atlanta Georgia
Research Site Roswell Georgia
Research Site Hoffman Estates Illinois
Research Site Naperville Illinois
Research Site Oak Brook Illinois
Research Site Indianapolis Indiana
Research Site Lafayette Indiana
Research Site Valparaiso Indiana
Research Site Prairie Village Kansas
Research Site Wichita Kansas
Research Site Shreveport Louisiana
Research SIte Glen Burnie Maryland
Research Site Braintree Massachusetts
Research Site Springfield Massachusetts
Research Site Clinton Township Michigan
Research Site Kalamazoo Michigan
Research Site Royal Oak Michigan
Research Site Saint Charles Missouri
Research Site St Louis Missouri
Research Site Cherry Hill New Jersey
Research Site Clementon New Jersey
Research Site Cedarhurst New York
Research Site New York New York
Research Site Olean New York
Research Site Rochester New York
Research Site Staten Island New York
Research Site Beechwood Ohio
Research Site Toledo Ohio
Research Site Norman Oklahoma
Research Site Oklahoma City Oklahoma
Research Site Philadelphia Pennsylvania
Research Site Lincoln Rhode Island
Research Site Columbia South Carolina
Research Site Memphis Tennessee
Research Site Friendswood Texas
Research Site Houston Texas
Research Site San Antonio Texas
Research SIte Wichita Falls Texas
Research Site Salt Lake City Utah
Research Site Arlington Virginia
Research Site Richmond Virginia
Research Site Bellevue Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Recently updated Major Depressive Disorder trials

Other public records listing Major Depressive Disorder. Sorted by last update posted; newest first. Not a recommendation.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00326105, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 24, 2009 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00326105 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →