Evidence map›Paper›PMID 31816478›Full record

Trial reportEpilepsy & behavior : E&B2020

Differential antiseizure medication sensitivity of the Affective Reactivity Index: A randomized controlled trial in new-onset pediatric focal epilepsy.

David W Loring, Kimford J Meador, Shlomo Shinnar, William Davis Gaillard, James W Wheless, Sudha K Kessler, Joan A Conry, Madison M Berl, Thomas G Burns, Tracy A Glauser and 2 more

Open access · greenAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Epilepsy & behavior : E&B, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 37% 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

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
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

12 authors at 9 institutions in 1 country.

David W LoringDepartments of Neurology and Pediatrics, Emory University, Atlanta, GA, United States of America. Electronic address: dloring@emory.edu.
Kimford J MeadorDepartment of Neurology & Neurological Sciences, Stanford University, Palo Alto, CA, United States of America.
Shlomo ShinnarDepartments of Neurology, Pediatrics, Epidemiology & Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States of America.
William Davis GaillardDepartment of Neurology, Children's National Health System, Washington, DC, United States of America.
James W WhelessDepartment of Pediatrics, Division of Neurology, University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Memphis, TN, United States of America.
Sudha K KesslerDivision of Neurology, Children's Hospital of Philadelphia, Departments of Neurology and Pediatrics, University of Pennsylvania, Philadelphia, PA, United States of America.
Joan A ConryDepartment of Neurology, Children's National Health System, Washington, DC, United States of America.
Madison M BerlDepartment of Neuropsychology, Children's National Health System, Washington, DC, United States of America.
Thomas G BurnsDepartment of Neuropsychology, Children's Healthcare of Atlanta, Atlanta, GA, United States of America.
Tracy A GlauserDivision of Neurology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States of America.
Becky KinkeadDepartment of Psychiatry and Behavioral Science, Emory University, Atlanta, GA, United States of America.
Avital CnaanDepartment of Pediatrics, George Washington University, Washington, DC, United States of America.
Children's National · USEmory University · USAlbert Einstein College of Medicine · USChildren's Healthcare of Atlanta · USChildren's Hospital of Philadelphia · USCincinnati Children's Hospital Medical Center · USGeorge Washington University · USStanford University · USUniversity of Tennessee Health Science Center · US

Funding

Research_ProjectU54HD090257 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI VITTORIO GALLO, VITTORIO GALLO VITTORIO GALLO · 2016 to 2020
$5.9M
NICHD NIH HHS U54 HD090257
6 · The paper itself

Abstract

backgroundIrritability is a adverse effect of many antiseizure medications (ASMs), but there are no validated measures currently available to characterize this behavioral risk. We examined both child and parent/guardian versions of the Affective Reactivity Index (ARI), a validated measure developed for application in adolescent psychiatry, to determine its sensitivity to ASM-related irritability. We hypothesized irritability increases associated with levetiracetam (LEV) but not lamotrigine (LTG) or oxcarbazepine (OXC).

methodThe ARI was administered to 71 child and parent/guardian pairs randomized to one of three common ASMs (LEV, LTG, OXC) used to treat new-onset focal (localization-related) epilepsy. Subjects were recruited as part of a prospective multicenter, randomized, open-label, parallel group design. The ARI was administered at baseline prior to treatment initiation and again at 3 months after ASM initiation.

resultsThere was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation. When examined on the individual subject level using a criterion of at least a 3-point ARI increase, there was an increase associated with LEV for child ratings but not parent/guardian scores.

conclusionBoth child and parent/guardian versions of the ARI appear sensitive to medication-induced irritability associated with LEV on both the group and individual levels. The findings extend the applicability of ARI from characterizing the presence of clinical irritability as a psychiatric diagnostic feature to a more modifiable aspect of behavior change related to medication management and support its use in clinical trial applications.

Indexed as

AdolescentAnticonvulsantsChildDose-Response Relationship, DrugEpilepsies, PartialFemaleHumansIrritable MoodLamotrigineLevetiracetamMaleOxcarbazepineProspective StudiesAnticonvulsantsLamotrigineLevetiracetamOxcarbazepineAffective Reactivity IndexAntiseizure medicationsIrritability

Identifiers

PMID31816478
PMCPMC7232830
OpenAlexW2993808625

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.