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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Brain imaging predictors and the international study to predict optimized treatment for depression: study protocol for a randomized controlled trial

Authors: Stuart M Grieve, Mayuresh S Korgaonkar, Amit Etkin, Anthony Harris, Stephen H Koslow, Stephen Wisniewski, Alan F Schatzberg, Charles B Nemeroff, Evian Gordon, Leanne M Williams

Published in: Trials | Issue 1/2013

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Abstract

Background

Approximately 50% of patients with major depressive disorder (MDD) do not respond optimally to antidepressant treatments. Given this is a large proportion of the patient population, pretreatment tests that predict which patients will respond to which types of treatment could save time, money and patient burden. Brain imaging offers a means to identify treatment predictors that are grounded in the neurobiology of the treatment and the pathophysiology of MDD.

Methods/Design

The international Study to Predict Optimized Treatment in Depression is a multi-center, parallel model, randomized clinical trial with an embedded imaging sub-study to identify such predictors. We focus on brain circuits implicated in major depressive disorder and its treatment. In the full trial, depressed participants are randomized to receive escitalopram, sertraline or venlafaxine-XR (open-label). They are assessed using standardized multiple clinical, cognitive-emotional behavioral, electroencephalographic and genetic measures at baseline and at eight weeks post-treatment. Overall, 2,016 depressed participants (18 to 65 years old) will enter the study, of whom a target of 10% will be recruited into the brain imaging sub-study (approximately 67 participants in each treatment arm) and 67 controls. The imaging sub-study is conducted at the University of Sydney and at Stanford University. Structural studies include high-resolution three-dimensional T1-weighted, diffusion tensor and T2/Proton Density scans. Functional studies include standardized functional magnetic resonance imaging (MRI) with three cognitive tasks (auditory oddball, a continuous performance task, and Go-NoGo) and two emotion tasks (unmasked conscious and masked non-conscious emotion processing tasks). After eight weeks of treatment, the functional MRI is repeated with the above tasks. We will establish the methods in the first 30 patients. Then we will identify predictors in the first half (n = 102), test the findings in the second half, and then extend the analyses to the total sample.

Trial registration

International Study to Predict Optimized Treatment - in Depression (iSPOT-D). ClinicalTrials.gov, NCT00693849.
Appendix
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Metadata
Title
Brain imaging predictors and the international study to predict optimized treatment for depression: study protocol for a randomized controlled trial
Authors
Stuart M Grieve
Mayuresh S Korgaonkar
Amit Etkin
Anthony Harris
Stephen H Koslow
Stephen Wisniewski
Alan F Schatzberg
Charles B Nemeroff
Evian Gordon
Leanne M Williams
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-224

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