Evidence map›Paper›PMID 27038550›Full record

Trial reportJournal of psychiatric research2016

Establishing moderators and biosignatures of antidepressant response in clinical care (EMBARC): Rationale and design.

Madhukar H Trivedi, Patrick J McGrath, Maurizio Fava, Ramin V Parsey, Benji T Kurian, Mary L Phillips, Maria A Oquendo, Gerard Bruder, Diego Pizzagalli, Marisa Toups and 12 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of psychiatric research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01407094 (Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care), which is not on this map. Cited by 183 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed, 5 pooled it
27.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01407094 phase2completednot on this map

Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) for Depression

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2011 to 2016Enrolled296ConditionsDepressionArmsSertraline, Placebo, BupropionXL
3 · Its place in the literature

Who cites it

183 citing papers in PubMed, 5 syntheses or guidelines pooled it, 293 citations in OpenAlex.

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  8. Towards causal inference-based antidepressant selection with brain and blood biomarkers.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026
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123 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 10 institutions in 1 country.

Madhukar H TrivediUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA. Electronic address: madhukar.trivedi@utsouthwestern.edu.
Patrick J McGrathNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
Maurizio FavaMassachusetts General Hospital, Boston, MA, USA.
Ramin V ParseyStony Brook University, Stony Brook, NY, USA.
Benji T KurianUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Mary L PhillipsUniversity of Pittsburgh, Pittsburgh, PA, USA.
Maria A OquendoNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
Gerard BruderNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
Diego PizzagalliHarvard Medical School - McLean Hospital, Boston, MA, USA.
Marisa ToupsUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Crystal CooperUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Phil AdamsNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
Sarah WeyandtUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
David W MorrisUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Bruce D GrannemannUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
R Todd OgdenColumbia University, New York, NY, USA.
Randy BucknerHarvard University, Cambridge, MA, USA.
Melvin McInnisUniversity of Michigan, Ann Arbor, MI, USA.
Helena C KraemerStanford University, Stanford, CA, USA.
Eva PetkovaNew York University, New York, NY, USA.
Thomas J CarmodyUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Myrna M WeissmanNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
The University of Texas Southwestern Medical Center · USColumbia University · USHarvard University Press · USMassachusetts General Hospital · USMcLean Hospital · USNew York University · USStanford University · USStony Brook University · USUniversity of Michigan–Ann Arbor · USUniversity of Pittsburgh · US

Funding

Establishing Moderators/Biosignatures of Antidepressant Response- Clinical CareU01MH092221 · NIMH · UT SOUTHWESTERN MEDICAL CENTER · PI TRIVEDI, MADHUKAR H. · 2010 to 2015
$9.7M
Biosignatures of Treatment Remission in Major DepressionU01MH092250 · NIMH · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MCGRATH, PATRICK J, PARSEY, RAMIN V. · 2010 to 2015
$8.9M
NIMH NIH HHS U01 MH092221NIMH NIH HHS U01 MH092250
6 · The paper itself

Abstract

unlabelledRemission 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 registrationEstablishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression (EMBARC). Identifier: NCT01407094. URL: http://clinicaltrials.gov/show/NCT01407094.

Indexed as

AdultAntidepressive AgentsBiomarkersBrainDouble-Blind MethodElectroencephalographyFemaleHumansMagnetic Resonance ImagingMajor Depressive DisorderMalePatient SelectionPrecision MedicinePsychiatric Status Rating ScalesQuinazolinesResearch DesignAntidepressive AgentsBiomarkersbuquineranQuinazolinesSertralineAntidepressant responseBiosignaturesEMBARCMediatorsModeratorsSertraline

Identifiers

PMID27038550
PMCPMC6100771
OpenAlexW2298299786

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.