Depression
Summary
iSPOT-D is the largest biomarker study ever undertaken in major Depressive Disorder (MDD). MDD is projected to cause the second greatest global burden of disease by 2020, highlighting the urgent need for valid predictors of effective treatment response. Currently, there are no accurate predictors of response to antidepressants in MDD, and successful treatment relies greatly on 'trial and error'.
The aim of this study is to identify genetic, brain and cognitive markers (or combinations of markers) that predict specific response to a range of antidepressants (sertraline, escitalopram, venlafaxine) in patients diagnosed with major depressive disorder (MDD). This ground breaking study, funded by Brain Resource, may change the way in which personalised medicine is implemented in depression.
Study Design
A total of 2,016 adult patients meeting DSM-IV criteria for MDD (nonpsychotic) and 672 age and sex-matched healthy controls will participate in this international, multi-site study. The Brain Dynamics Centre, aims to recruit and assess 210 MDD adult patients and 50 age and sex-matched healthy controls across a two year period. Patients will be identified via primary and psychiatric care settings as well as through advertisements to the general public. Controls will be recruited from community advertisements and university subject pools to control for repeated exposure to stimuli.
MDD participants will each be randomized (open label) into one of the 3 antidepressant classes:
Escitalopram (SSRI), Sertraline (SSRI) and Venlafaxine (SNRI).
Study Timeline
Subjects will be asked to attend the testing facility on two separate occasions:
Baseline: Participants are first tested un-medicated. At the end of this testing session, patients are given a letter addressed to their treating clinician with their randomized medication.
Post-medication Testing: After 8 weeks, participants return for on-medication testing.
Participant will also receive a total of 8 short phone call interviews at assess their symptoms (day 4, wk 2 wk 4, wk 6, wk 12, wk 16, wk 24 and wk 52).
Testing
Baseline and post-medication testing (Wk 8) will involve a clinical interview, a computerized cognitive test battery, questionnaires, a neurophysiological recording of brain activity and a urine based drug screen. Structural and functional MRI scan will be collected in ten percent of participants. At baseline, a blood collection (for pathology and genomic analyses) and pregnancy test (if applicable) will be completed.
Each patient’s referring doctor will be sent a detailed, evidence-based off & on medication report comparing their patient’s performance on the clinical interview (depression diagnosis and severity), symptoms and cognitive test battery compared to age and sex-matched controls. Participants who complete the MRI scan will also receive an MRI report.
Results can be used as part of the doctor’s assessment of treatment response.
Project name: International Study to Predict Optimised Treatment – in Depression
Funding: Brain Resource
Investigators: A/Prof Anthony Harris, Prof Lea Williams, Prof Tim Usherwood
Post-doctoral fellow coordinator: Dr Yun Ju Christine Song
PhD students: Ms Claire Day
For further information, please contact Brain Dynamics Centre, Westmead Millennium Institute at yun.song@sydney.edu.au or at 9845 6844
