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 depressive symptoms in 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 3

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 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: Anxiety Depression

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: No ]
MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value.

Secondary Outcome Measures:

Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q) [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: No ]
Q-LES-Q as percent of maximum (0 to 100%) calculated as Week 9 - baseline, where higher values indicate better quality of life.
Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q) [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: No ]
Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value
Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A) [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: No ]
Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety.
Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: No ]
The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0
Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: Yes ]
The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0
Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A) [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: No ]
The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0
Tolerability as Measured by Adverse Event Withdrawals During Treatment [ Time Frame: Baseline to Week 9 ] [ Designated as safety issue: Yes ]

Enrollment:	338
Study Start Date:	September 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (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 mental disorder other 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

No publications provided

Responsible Party:	Martin Brecher, Seroquel Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00388973 History of Changes
Other Study ID Numbers:	D1448C00014, EUDRACT No: 2006-001196-38
Study First Received:	October 16, 2006
Results First Received:	December 29, 2008
Last Updated:	March 22, 2010
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 of the Russian Federation Ukraine: Ministry of Health

Keywords provided by AstraZeneca:

Major Depressive Disorder
MDD

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 May 22, 2013