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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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 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 Paroxetine hydrochloride hemihydrate 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:	May 2006
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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00351910 History of Changes
Other Study ID Numbers:	D1448C00007, ONYX, EUDRACT No: 2005-0055053-22
Study First Received:	July 12, 2006
Last Updated:	January 25, 2011
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:

Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Amitriptyline
Duloxetine
Antidepressive Agents
Citalopram
Fluoxetine
Paroxetine
Sertraline
Venlafaxine
Bupropion

Amitriptyline, perphenazine drug combination
Dexetimide
Quetiapine
Antidepressive Agents, Tricyclic
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on February 09, 2012