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

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.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: Quetiapine	Phase III

MedlinePlus related topics:

Depression

ChemIDplus related topics:

Quetiapine Quetiapine fumarate

U.S. FDA Resources

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

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

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

Responsible Party:	AstraZeneca Pharmaceuticals ( Martin Brecher, Seroquel Medical Science Director )
Study ID Numbers:	D1448C00014, EUDRACT No: 2006-001196-38
First Received:	October 16, 2006
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00388973
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Finland: National Agency for Medicines; 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

Study placed in the following topic categories:

Quetiapine

Depression

Mental Disorders

Mood Disorders

Depressive Disorder, Major

Depressive Disorder

Behavioral Symptoms

Additional relevant MeSH terms:

Tranquilizing Agents

Pathologic Processes

Disease

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antipsychotic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

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