Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00388973

Purpose

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with 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	Phase III

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

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:

The primary objective of this study is to evaluate the change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score [ Time Frame: Assessed from randomisation to the end of the treatment (Day 64). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary objectives are to evaluate the changes (e.g. in health-related quality of life, anxiety symptoms and sleep quality) [ Time Frame: Assessed by different questionnaires, from randomisation to the end of the treatment (Day 64). ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	September 2006
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	66 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients, 66 years or older, with a documented clinical diagnosis of MDD.

Exclusion Criteria:

The presence of dementia or other mental disorder than MDD within 6 months of enrolment,
Uncontrolled hypertension, substance or alcohol abuse
A current diagnosis of cancer or a current or past diagnosis of stroke

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388973

Show 43 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Catherine Datto, MD

AstraZeneca

More Information

Additional Information:

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

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Martin Brecher, Seroquel Medical Science Director )
Study ID Numbers:	D1448C00014, EUDRACT No: 2006-001196-38
Study First Received:	October 16, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00388973 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Finland: Finnish Medicines Agency; Estonia: The State Agency of Medicine; Lithuania: State Medicine Control Agency - Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health

Keywords provided by AstraZeneca:

Major Depressive Disorder
MDD

Additional relevant MeSH terms:

Depression
Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Depressive Disorder, Major
Depressive Disorder
Antipsychotic Agents

Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009