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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
History of Changes
  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
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:

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):

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 May 23, 2013