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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00351910
First received: July 12, 2006
Last updated: January 25, 2011
Last verified: January 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


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   (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Study First Received: July 12, 2006
Last Updated: January 25, 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
Bupropion
Citalopram
Venlafaxine Hydrochloride
Fluoxetine
Paroxetine
Duloxetine Hydrochloride
Antidepressive Agents
Sertraline
Amitriptyline
Amitriptyline, perphenazine drug combination
Quetiapine Fumarate
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 26, 2017