Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00351169

Purpose

To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Quetiapine SR Drug: Escitalopram	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Quetiapine Quetiapine fumarate Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate the efficacy of quetiapine SR compared with placebo in the treatment of patients with major depressive disorder (MDD) as assessed by change from randomisation to week 8 score in the MADRS total score.

Secondary Outcome Measures:

If quetiapine SR improves health-related quality of life of patients with MDD, compared to placebo

Estimated Enrollment:	450
Study Start Date:	May 2006
Study Completion Date:	June 2007

Eligibility

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

Criteria

Inclusion Criteria:

Male or female aged 18 to 65 years
A documented diagnosis of major depressive disorder

Exclusion Criteria:

Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351169

Show 42 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Willie Earley, MD

AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D1448C00004, AMBER, EUDRACT No: 2005-005052-40
Study First Received:	July 11, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00351169 History of Changes
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by AstraZeneca:

Major Depressive Disorder
MDD

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Pathologic Processes
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Depression

Tranquilizing Agents
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Serotonin Agents
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009