Major Depressive Disorder Clinical Trial
Official title:
International Study to Predict Optimised Treatment - in Depression
The aim of this study is to identify genetic, physical (brain) and psychological (cognitive) markers (or combinations of them) that predict specific response to a range of antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with major depressive disorder. This study is focused on outcomes which may impact on how "personalised medicine" is implemented in depression.
This is an open-label, randomised (effectiveness) study (ie. comparison of active treatments)
to identify genetic markers, brain function, brain structure, and psychological and cognitive
indicators (or a combination of markers) in MDD subjects versus healthy controls.
Approximately 2,016 subjects with major depressive disorder (MDD) across multiple
international sites (USA, Canada, UK, South Africa, New Zealand, The Netherlands and
Australia) will be randomised to one of three approved and effective treatment arms:
Treatment A Escitalopram. Treatment B Sertraline. Treatment C Venlafaxine XR.
A group of matched healthy controls (n = 672) will also be enrolled.
Subjects will be asked to attend the testing facility on two separate occasions; for
Pre-treatment (Pre-Tx) and at 8 weeks post initiation of treatment. The
assessments/procedures at Pre-Tx and Week 8 include: Baseline a clinical work-up, blood
collection for genetic analyses, cognitive testing and electrical brain functioning
(EEG/ERP). Structural and functional data MRI data will be collected in ten percent (10%) of
participants.
On Day 4 and Weeks 2, 4, 6, 12, 16, 24 and 52 Subjects will be contacted by phone and asked
to complete 2 questionnaires via the internet.
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