Evidence map›Paper›PMID 38941338›Full record

ArticlePloS one2024

Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol.

Maria I Lapid, Julia Merrill, Martina Mueller, Adriana P Hermida, Louis Nykamp, Jason Andrus, Heela Azizi, Paula Bolton, Nana Bonsu, Raphael Braga and 42 more

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Article
  2. Article
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

52 authors.

Maria I LapidDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, United States of America.ORCID 0000-0002-1163-5584
Julia MerrillMcLean Hospital, Belmont, Massachusetts, United States of America.ORCID 0009-0004-6081-4900
Martina MuellerCollege of Nursing, Medical University of South Carolina, Charleston, South Carolina, United States of America.ORCID 0000-0003-2041-5142
Adriana P HermidaDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Louis NykampPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Jason AndrusNorthwell, New Hyde Park, New York, United States of America.
Heela AziziNorthwell, New Hyde Park, New York, United States of America.
Paula BoltonMcLean Hospital, Belmont, Massachusetts, United States of America.
Nana BonsuDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Raphael BragaNorthwell, New Hyde Park, New York, United States of America.
Catherine R DillonDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Donna EcklesdaferPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Darci EvansPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
David HarperMcLean Hospital, Belmont, Massachusetts, United States of America.
Hannah HeintzMcLean Hospital, Belmont, Massachusetts, United States of America.ORCID 0000-0003-0438-9351
Sehba Hussain-KrauterIcan School of Medicine at Mount Sinai, New York, New York, United States of America.
Olivia HolzgenPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Daniel HumphreyCollege of Nursing, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Salima JiwaniNorthwell, New Hyde Park, New York, United States of America.
Emily K JohnsonDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, United States of America.
Simran KangNorthwell, New Hyde Park, New York, United States of America.
Janelle KassienPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.ORCID 0009-0009-0660-3578
Jonathan KimDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Rebecca G KnappDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Simon KungDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, United States of America.
Neil KremenNorthwell, New Hyde Park, New York, United States of America.
Kendra LeDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Jack MahdasianPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Taylor MarzoukNorthwell, New Hyde Park, New York, United States of America.
Jared D MasrudDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, United States of America.
Jefferson MattinglyMcLean Hospital, Belmont, Massachusetts, United States of America.
Dawn MillerPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Sandeep R PagaliDivision of Hospital Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minnesota, United States of America.ORCID 0000-0002-0838-1026
Regan PatrickMcLean Hospital, Belmont, Massachusetts, United States of America.ORCID 0000-0002-6421-2665
Patricio Riva PosseDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Cristina PritchettDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Aniqa RahmanMcLean Hospital, Belmont, Massachusetts, United States of America.
Swapnil RathPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Cara RoczniakPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Teresa A RummansDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, United States of America.
Sohag SanghaniNorthwell, New Hyde Park, New York, United States of America.
Steve SeinerNorthwell, New Hyde Park, New York, United States of America.
LeAnn SmartPine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.ORCID 0000-0003-0153-0153
Evan TomaschekDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Valeriya TsygankovaDepartment of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Lori VanderSchuur-WhitePine Rest Christian Mental Health Services, Grand Rapids, Michigan, United States of America.
Monica P WaltonOregon Health & Science University, Portland, Oregon, United States of America.
James WilkinsMcLean Hospital, Belmont, Massachusetts, United States of America.
April WilliamsDepartment of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, United States of America.
Sarah M WilliamsDepartment of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota, United States of America.
George PetridesNorthwell, New Hyde Park, New York, United States of America.
Brent P ForesterMcLean Hospital, Belmont, Massachusetts, United States of America.

Funding

A Randomized Controlled Trial of Electroconvulsive Therapy plus Usual Care versus Simulated-ECT plus Usual Care for the Acute Management of Severe Agitation in Alzheimer's Dementia (ECT-AD)R01AG061100 · NIA · MCLEAN HOSPITAL · PI FORESTER, BRENT PETER, PETRIDES, GEORGIOS · 2018 to 2023
$9.4M
NIA NIH HHS R01 AG061100
6 · The paper itself

Abstract

objectiveThis study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented.

methodsInitially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants.

resultsStudy is ongoing and open to enrollment.

conclusionThe transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

Indexed as

DementiaElectroconvulsive TherapyPsychomotor AgitationAberrant Motor Behavior in DementiaAgedFemaleHumansMaleRandomized Controlled Trials as TopicSingle-Blind MethodTreatment Outcome

Identifiers

PMID38941338
PMCPMC11213353

What OpenQuestion holds

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Registered trials

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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.