Evidence map›Paper›PMID 28670629›Full record

ArticleContemporary clinical trials communications2017

Statistical Analysis Plan for Stage 1 EMBARC (Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care) Study.

Eva Petkova, R Todd Ogden, Thaddeus Tarpey, Adam Ciarleglio, Bei Jiang, Zhe Su, Thomas Carmody, Philip Adams, Helena C Kraemer, Bruce D Grannemann and 6 more

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2017. 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 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Multiple domain and multiple kernel outcome-weighted learning for estimating individualized treatment regimes.Journal of computational and graphical statistics : a joint publication of American Statistical Association, Institute of Mathematical Statistics, Interface Foundation of North America · 2022
    Article
  8. Article
  9. Article
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  12. Review
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

16 authors.

Eva PetkovaNew York University, New York and Nathan Kline Institute for Psychiatric Research, Orangeburg, NY, USA.
R Todd OgdenColumbia University, New York, NY, USA.
Thaddeus TarpeyWright State University, Dayton, OH, and New York University, New York, NY, USA.
Adam CiarleglioNew York University and Columbia University, New York, NY, USA.
Bei JiangUniversity of Alberta, Edmonton, Alberta, Canada.
Zhe SuNew York University, New York, NY, USA.
Thomas CarmodyUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Philip AdamsNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
Helena C KraemerStanford University, Stanford, CA, USA.
Bruce D GrannemannUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.
Maria A OquendoNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
Ramin ParseyStony Brook University, Stony Brook, NY, USA.
Myrna WeissmanNew York State Psychiatric Institute & Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.
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.
Madhukar H TrivediUniversity of Texas, Southwestern Medical Center, Dallas, TX, USA.

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
Characterizing Placebo ResponseR01MH099003 · NIMH · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI PETKOVA, EVA, TARPEY, THADDEUS · 2013 to 2021
$4.5M
NIMH NIH HHS R01 MH099003NIMH NIH HHS U01 MH092221NIMH NIH HHS U01 MH092250
6 · The paper itself

Abstract

Antidepressant medications are commonly used to treat depression, but only about 30% of patients reach remission with any single first-step antidepressant. If the first-step treatment fails, response and remission rates at subsequent steps are even more limited. The literature on biomarkers for treatment response is largely based on secondary analyses of studies designed to answer primary questions of efficacy, rather than on a planned systematic evaluation of biomarkers for treatment decision. The lack of evidence-based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially designed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary. Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) is one such discovery study. Stage 1 of EMBARC is a randomized placebo controlled clinical trial of 8 week duration. A wide array of patient characteristics is collected at baseline, including assessments of brain structure, function and connectivity along with electrophysiological, biological, behavioral and clinical features. This paper reports on the data analytic strategy for discovering biosignatures for treatment response based on Stage 1 of EMBARC.

Indexed as

combining biomarkersdifferential treatment response indexmoderatoroptimizing treatment decisionsprecision medicine

Identifiers

PMID28670629
PMCPMC5485858

What OpenQuestion holds

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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.