Evidence map›Paper›PMID 33896622›Full record

ArticleBiological psychiatry2021

Establishing Evidence for Clinical Utility of a Neuroimaging Biomarker in Major Depressive Disorder: Prospective Testing and Implementation Challenges.

Mary E Kelley, Ki Sueng Choi, Justin K Rajendra, W Edward Craighead, Jeffrey J Rakofsky, Boadie W Dunlop, Helen S Mayberg

Erratum issuedOpen access · greenAbstract read
In one paragraph

Article in Biological psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Breakthroughs and challenges for generating brain network-based biomarkers of treatment response in depression.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Review
  9. Article
  10. Brain-based graph-theoretical predictive modeling to map the trajectory of anhedonia, impulsivity, and hypomania from the human functional connectome.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Article
  11. Article
  12. Article
  13. Balancing the beautiful and the good in pursuit of biomarkers for depression.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2023
    Article
  14. [Effect of Sertraline on Serum Cytokine Levels in Adolescents With First-Episode Major Depressive Disorder].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2023
    Article
  15. Review
  16. Article
  17. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Mary E KelleyDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, Georgia. Electronic address: mekelle@emory.edu.
Ki Sueng ChoiCenter for Advanced Circuit Therapeutics, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, New York.
Justin K RajendraScientific and Statistical Computing Core, National Institute of Mental Health/National Institutes of Health/U.S. Department of Health and Human Services, Bethesda, Maryland.
W Edward CraigheadDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia; Department of Psychology, Emory University, Atlanta, Georgia.
Jeffrey J RakofskyDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia.
Boadie W DunlopDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia.
Helen S MaybergCenter for Advanced Circuit Therapeutics, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York.
Emory University · USCircuit Therapeutics (United States) · USNational Institutes of Health · US

Funding

Scientific and Statistical Computing CoreZICMH002888 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI TAYLOR, PAUL · 2009 to 2025
$30.9M
Testing an Imaging Biomarker for Treatment Stratification in Major DepressionR01MH073719 · NIMH · EMORY UNIVERSITY · PI DUNLOP, BOADIE W · 2006 to 2018
$5.8M
NIMH NIH HHS R01 MH073719
6 · The paper itself

Abstract

backgroundAlthough a number of neuroimaging biomarkers for response have been proposed, none have been tested prospectively for direct effects on treatment outcomes. To the best of our knowledge, this is the first prospective test of the clinical utility of the use of an imaging biomarker to select treatment for patients with major depressive disorder.

methodsEligible participants (n = 60) had a primary diagnosis of major depressive disorder and were assigned to either escitalopram or cognitive behavioral therapy based on fluorodeoxyglucose positron emission tomography activity in the right anterior insula. The overall study remission rate after 12 weeks of treatment, based on the end point Hamilton Depression Rating Scale score, was then examined for futility and benefit of the strategy.

resultsRemission rates demonstrated lack of futility at the end of stage 1 (37%, 10/27), and the study proceeded to stage 2. After adjustment for the change in stage 2 sample size, the complete remission rate did not demonstrate evidence of benefit (37.7%, 95% confidence interval, 26.3%-51.4%, p = .38). However, total remission rates (complete and partial remission) did reach significance in post hoc analysis (49.1%, 95% confidence interval, 37.6%-60.7%, p = .020).

conclusionsThe study shows some evidence for a role of the right anterior insula in the clinical choice of major depressive disorder monotherapy. The effect size, however, is insufficient for the use of insula activity as a sole predictive biomarker of remission. The study also demonstrates the logistical difficulties in establishing clinical utility of biomarkers.

Indexed as

Major Depressive DisorderBiomarkersCitalopramHumansNeuroimagingProspective StudiesSelective Serotonin Reuptake InhibitorsTreatment OutcomeBiomarkersCitalopramSelective Serotonin Reuptake InhibitorsAntidepressantClinical trialCognitive behavioral therapy (CBT)Major depressive disorder (MDD)NeuroimagingPositron emission tomography (PET)Selective serotonin reuptake inhibitor (SSRI)Treatment response

Identifiers

PMID33896622
PMCPMC8324510
OpenAlexW3133573452

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.