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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00351910

Purpose

To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in 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 Drug: Amitriptyline Drug: Bupropion Drug: Citalopram Drug: Duloxetine Drug: Escitalopram Drug: Fluoxetine Drug: Paroxetine Drug: Sertraline Drug: Venlafaxine	Phase III

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Sertraline hydrochloride Sertraline Fluoxetine Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Paroxetine Paroxetine hydrochloride Paroxetine Mesylate Quetiapine Quetiapine fumarate Amitriptyline Amitriptyline hydrochloride Bupropion hydrochloride Bupropion Venlafaxine Venlafaxine hydrochloride Duloxetine Duloxetine hydrochloride Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, 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 SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major Depressive Disorder With Inadequate Response to an Antidepressant Treatment

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate the efficacy of quetiapine fumarate sustained release
(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.

Secondary Outcome Measures:

If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.

Enrollment:	494
Study Start Date:	September 2005
Study Completion Date:	April 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: NCT00351910

Show 74 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

More Information

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

Study ID Numbers:	D1448C00007, ONYX, EUDRACT No: 2005-0055053-22
Study First Received:	July 12, 2006
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00351910
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines; Australia: Department of Health and Ageing Therapeutic Goods Administration; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; Poland: Ministry of Health; South Africa: Medicines Control Council; Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Major Depressive Disorder
MDD

Study placed in the following topic categories:

Depression
Depressive Disorder, Major
Depressive Disorder
Citalopram
Paroxetine
Serotonin
Duloxetine
Behavioral Symptoms
Fluoxetine

Quetiapine
Dopamine
Mental Disorders
Venlafaxine
Bupropion
Mood Disorders
Amitriptyline
Sertraline
Dexetimide

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Analgesics
Antidepressive Agents, Second-Generation

Antidepressive Agents
Disease
Tranquilizing Agents
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Serotonin Agents
Analgesics, Non-Narcotic
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009