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Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder (ONYX)

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ClinicalTrials.gov Identifier: NCT00351910
Recruitment Status : Completed
First Posted : July 13, 2006
Last Update Posted : January 26, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:

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 or disease Intervention/treatment 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 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 494 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2006
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351910


  Show 74 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Seroquel Medical Science Director, MD AstraZeneca

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

ClinicalTrials.gov Identifier: NCT00351910     History of Changes
Other Study ID Numbers: D1448C00007
ONYX
EUDRACT No: 2005-0055053-22
First Posted: July 13, 2006    Key Record Dates
Last Update Posted: January 26, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Major Depressive Disorder
MDD

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Bupropion
Duloxetine Hydrochloride
Sertraline
Fluoxetine
Paroxetine
Venlafaxine Hydrochloride
Amitriptyline
Amitriptyline, perphenazine drug combination
Quetiapine Fumarate
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Dopamine Agents