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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00351910
Registration number
NCT00351910
Ethics application status
Date submitted
12/07/2006
Date registered
13/07/2006
Date last updated
26/01/2011
Titles & IDs
Public title
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
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Scientific 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
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Secondary ID [1]
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ONYX
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Secondary ID [2]
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D1448C00007
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Universal Trial Number (UTN)
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Trial acronym
ONYX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Quetiapine
Treatment: Drugs - Amitriptyline
Treatment: Drugs - Bupropion
Treatment: Drugs - Citalopram
Treatment: Drugs - Duloxetine
Treatment: Drugs - Escitalopram
Treatment: Drugs - Fluoxetine
Treatment: Drugs - Paroxetine
Treatment: Drugs - Sertraline
Treatment: Drugs - Venlafaxine
Treatment: Drugs: Quetiapine
Treatment: Drugs: Amitriptyline
Treatment: Drugs: Bupropion
Treatment: Drugs: Citalopram
Treatment: Drugs: Duloxetine
Treatment: Drugs: Escitalopram
Treatment: Drugs: Fluoxetine
Treatment: Drugs: Paroxetine
Treatment: Drugs: Sertraline
Treatment: Drugs: Venlafaxine
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate the efficacy of quetiapine fumarate sustained release
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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(Seroquel SR™) in combination with an antidepressant versus an antidepressant alone in patients with Major Depressive Disorder.
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [1]
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If quetiapine SR in combination with an antidepressant improves health-related quality of life of patients with MDD, compared to an antidepressant alone.
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Male or female aged 18 to 65 years
- A documented diagnosis of major depressive disorder
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2007
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Sample size
Target
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Accrual to date
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Final
494
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Research Site - Everton Park
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Research Site - Southport
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Research Site - Brisbane
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- Everton Park
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- Southport
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- Frankston
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- Malvern
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- Prahran
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- Richmond
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- Brisbane
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Belgium
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Assebroek
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Belgium
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Brussels
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00351910
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Seroquel Medical Science Director, MD
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Address
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00351910
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