Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder - Full Text View

Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder (MOONSTONE)

This study has been completed.

First Received on May 1, 2006. Last Updated on March 24, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00320268

Purpose

This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Quetiapine fumarate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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®) as Monotherapy in the Treatment of Patients With MDD

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures:

Change from randomization to each assessment in the MADRS total score
MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6

Estimated Enrollment:	600
Study Start Date:	April 2006
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient has a documented clinical diagnosis of Major Depressive Disorder.
Be able to understand and comply with the requirements of the study.
Able to understand and provide written informed consent

Exclusion Criteria:

Patients (female) must not be pregnant or lactating
Current or past diagnosis of stroke or transient ischemic attack (TIA).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320268

Show 37 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Art Lazarus, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

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

Weisler RH, Montgomery SA, Earley WR, Szamosi J, Lazarus A. Efficacy of extended release quetiapine fumarate monotherapy in patients with major depressive disorder: a pooled analysis of two 6-week, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2012 Jan;27(1):27-39.

Weisler R, Joyce M, McGill L, Lazarus A, Szamosi J, Eriksson H; Moonstone Study Group. Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study. CNS Spectr. 2009 Jun;14(6):299-313.

ClinicalTrials.gov Identifier:	NCT00320268 History of Changes
Other Study ID Numbers:	D1448C00001, Moonstone
Study First Received:	May 1, 2006
Last Updated:	March 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

MDD
Quetiapine fumarate, sustained release
Depression

Additional relevant MeSH terms:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Quetiapine
Antipsychotic Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012