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:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

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

U.S. FDA Resources

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

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Locations

Australia
Research Site
Brisbane, Australia
Australia, Queensland
Research Site
Everton Park, Queensland, Australia
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Southport, Queensland, Australia
Australia, Victoria
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Frankston, Victoria, Australia
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Malvern, Victoria, Australia
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Prahran, Victoria, Australia
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Richmond, Victoria, Australia
Belgium
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Assebroek, Belgium
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Brussels, Belgium
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Gent, Belgium
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Kortrijk, Belgium
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Liege, Belgium
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MECHELEN, Belgium
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TIELT, Belgium
Canada, Alberta
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EDMONTON, Alberta, Canada
Canada, New Brunswick
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MONCTON, New Brunswick, Canada
Canada, Newfoundland and Labrador
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MOUNT PEARL, Newfoundland and Labrador, Canada
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ST. JOHN'S, Newfoundland and Labrador, Canada
Canada, Nova Scotia
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HALIFAX, Nova Scotia, Canada
Canada, Ontario
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TORONTO, Ontario, Canada
Canada, Quebec
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POINTE-CLAIRE, Quebec, Canada
Czech Republic
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Olomouc, Czech Republic
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Brno, Czech Republic
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Praha 10, Czech Republic
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Havlickuv Brod, Czech Republic
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Nove Mesto nad Metuji, Czech Republic
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Ostrava, Czech Republic
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Havirov, Czech Republic
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Praha 5, Czech Republic
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Praha 8, Czech Republic
Finland
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Helsinki, Finland
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Jarvenpaa, Finland
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Salo, Finland
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Turku, Finland
France
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Angouleme, France
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Arcachon, France
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Caen, France
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Chateau Gontier, France
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Elancourt, France
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Le Pecq, France
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Nimes, France
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Paris, France
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Rennes, France
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Toulouse, France
Germany
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Augsburg, Germany
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Berlin, Germany
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Koln, Germany
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Munster, Germany
Norway
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Bergen, Norway
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Flekkefjord, Norway
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Fyllingsdalen, Norway
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Hamar, Norway
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Lysaker, Norway
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Oslo, Norway
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SKIEN, Norway
Poland
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Gdansk, Poland
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Nowy Targ, Poland
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Lodz, Poland
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Szczecin, Poland
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Torun, Poland
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Warszawa, Poland
Romania
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BUCHAREST, Romania
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PITESTI, Romania
South Africa, Gauteng
Research Site
Pretoria, Gauteng, South Africa
South Africa, Kwazulu-Natal
Research Site
Durban, Kwazulu-Natal, South Africa
South Africa, Western Cape
Research Site
Cape Town, Western Cape, South Africa
Sweden
Research Site
Falkoping, Sweden
Research Site
Halmstad, Sweden
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GÖTEBORG, Sweden
Research Site
Malmo, Sweden
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Uppsala, Sweden
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Sundsvall, Sweden
Research Site
Trollhattan, Sweden
Research Site
Stockholm, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Seroquel Medical Science Director, MD

AstraZeneca

More Information

Additional Information:

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Bauer M, Pretorius HW, Constant EL, Earley WR, Szamosi J, Brecher M. Extended-release quetiapine as adjunct to an antidepressant in patients with major depressive disorder: results of a randomized, placebo-controlled, double-blind study. J Clin Psychiatry. 2009 Apr;70(4):540-9. Epub 2009 Apr 7.

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 History of Changes
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: Finnish Medicines Agency; 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

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Paroxetine
Duloxetine
Pathologic Processes
Sensory System Agents
Mental Disorders
Therapeutic Uses

Venlafaxine
Sertraline
Analgesics
Antidepressive Agents, Second-Generation
Antidepressive Agents
Tranquilizing Agents
Disease
Depression
Central Nervous System Depressants
Antipsychotic Agents
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 27, 2009