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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

NCT00326105•AstraZeneca

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (56)

Research Site

Phoenix, Arizona, United States

Research Site

El Centro, California, United States

Research Site

Irvine, California, United States

Research Site

Oceanside, California, United States

Research Site

San Diego, California, United States

Research Site

Pueblo, Colorado, United States

Research Site

Coral Springs, Florida, United States

Research Site

DeLand, Florida, United States

Research Site

Gainsville, Florida, United States

Research Site

Hialeah, Florida, United States

Key Dates

Start Date

April 1, 2006

Completion Date

July 1, 2007

Last Updated

March 25, 2009

Enrollment

450

ESTIMATED participants

Conditions

Major Depressive Disorder

Interventions

Quetiapine fumarate

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

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Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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