Establishing moderators and biosignatures of antidepressant response in clinical care (EMBARC): Rationale and design
Open accessAbstract
Unlabelled Remission rates for Major Depressive Disorder (MDD) are low and unpredictable for any given antidepressant. No biological or clinical marker has demonstrated sufficient ability to match individuals to efficacious treatment. Biosignatures developed from the systematic exploration of multiple biological markers, which optimize treatment selection for individuals (moderators) and provide early indication of ultimate treatment response (mediators) are needed. The rationale and design of a multi-site, placebo-controlled randomized clinical trial of sertraline examining moderators and mediators of treatment response is described. The target sample is 300 participants with early onset (≤30 years) recurrent MDD. Non-responders to an 8-week trial are switched double blind to either bupropion (for sertraline non-responders) or sertraline (for placebo non-responders) for an additional 8 weeks. Clinical moderators include anxious depression, early trauma, gender, melancholic and atypical depression, anger attacks, Axis II disorder, hypersomnia/fatigue, and chronicity of depression. Biological moderator and mediators include cerebral cortical thickness, task-based fMRI (reward and emotion conflict), resting connectivity, diffusion tensor imaging (DTI), arterial spin labeling (ASL), electroencephalograpy (EEG), cortical evoked potentials, and behavioral/cognitive tasks evaluated at baseline and week 1, except DTI, assessed only at baseline. The study is designed to standardize assessment of biomarkers across multiple sites as well as institute replicable quality control methods, and to use advanced data analytic methods to integrate these markers. A Differential Depression Treatment Response Index (DTRI) will be developed. The data, including biological samples (DNA, RNA, and plasma collected before and during treatment), will become available in a public scientific repository.Clinical trial registration Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression (EMBARC). Identifier: NCT01407094. URL: http://clinicaltrials.gov/show/NCT01407094.
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The nature of care as usual or treatment as usual depends heavily on the health care system of the country and the study setting, ranging from almost no care to specialised mental health care by well-trained professionals.
“The nature of care as usual or treatment as usual depends heavily on the health care system of the country and the study setting, ranging from (almost) no care to specialised mental health care by well-trained professionals. 594”
From Time for united action on depression: a Lancet–World Psychiatric Association Commission (2022) · cites this paper as [594]
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Self-citationIntegrative Biological Analysis For Neuropsychopharmacology
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“Similarly, the rates of response [score less than “much improved” on the Clinical Global Improvement scale at the end of stage 1 as defined a priori by (Trivedi et al., 2016)] with sertraline and placebo were 46.”
MethodTrombello, J. M., Pizzagalli, D. A., Weissman, M. M., Grannemann, B. D., Cooper, C. M., Greer, T. L., Malchow, A. L., Jha, M. K., Carmody, T. J., Kurian, B. T., et al. (2018) · Journal of Psychiatric Research · doi:10.1016/j.jpsychires.2018.04.003 · Cited by 16 · see citing works
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- Authors
- Trivedi, M. H., McGrath, P. J., Fava, M., Parsey, R. V., Kurian, B. T., Phillips, M. L., Oquendo, M. A., Bruder, G., Pizzagalli, D., Toups, M., Cooper, C., Adams, P., Weyandt, S., Morris, D. W., Grannemann, B. D., Ogden, R. T., Buckner, R., McInnis, M., Kraemer, H. C., Petkova, E., Carmody, T. J., & Weissman, M. M.
- Affiliations
- The University of Texas Southwestern Medical Center (US)
- New York State Psychiatric Institute (US)
- Stony Brook University (US)
- University of Pittsburgh (US)
- Harvard University (US)
- Columbia University (US)
- University of Michigan (US)
- Stanford University (US)
- New York University (US)
- Corresponding author
- Trivedi, Madhukar H.
- ORCID
- Venue
- Journal of Psychiatric Research
- Publisher
- Elsevier BV
- Published
- 2016-07
- Volume
- 78
- Pages
- 11-23
- ISSN
- 0022-3956 (ISSN-L)
- PMC
- PMC6100771
- OpenAlex
- W2298299786
- Cited by
- 286
- References
- 102
- Citations by year
- 2026: 16 · 2025: 32 · 2024: 31 · 2023: 26 · 2022: 28 · 2021: 23 · 2020: 36 · 2019: 34 · 2018: 26 · 2017: 21 · 2016: 7 · 2015: 2 · 2014: 2 · 2013: 2
- FWCI
- 23.77
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Journal of Psychiatric Research (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Columbia Academic Commons (Columbia University)
- Funders
- National Institute of Mental Health of the National Institutes of Health (U01MH092221, U01MH092250)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- major depressive disorder, antidepressant response, treatment moderators, biosignatures, sertraline, bupropion, biomarkers, resting-state functional connectivity, diffusion tensor imaging, arterial spin labeling, EEG, treatment-resistant depression
- MeSH terms
- Adult, Antidepressive Agents, Brain, Major Depressive Disorder, Double-Blind Method, Electroencephalography, Female, Humans, Magnetic Resonance Imaging, Male, Psychiatric Status Rating Scales, Quinazolines, Research Design, Biomarkers, Treatment Outcome, Patient Selection, Sertraline, Precision Medicine
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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