Evidence map›Paper›PMID 20010551›Full record

Trial reportNeuropsychopharmacology : official publication of the American College of Neuropsychopharmacology2010

Divalproex sodium vs placebo for the treatment of irritability in children and adolescents with autism spectrum disorders.

Eric Hollander, William Chaplin, Latha Soorya, Stacey Wasserman, Sherry Novotny, Jade Rusoff, Nicole Feirsen, Lauren Pepa, Evdokia Anagnostou

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 60 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 9 pooled it
4.8field-weighted citation impact, top 5% 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

60 citing papers in PubMed, 9 syntheses or guidelines pooled it, 221 citations in OpenAlex.

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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

9 authors at 4 institutions in 3 countries.

Eric HollanderDepartment of Psychiatry, Montefiore Medical Center University Hospital for Albert Einstein College of Medicine, Child Psychiatry Annex, Bronx, NY 10467-2490, USA. eholland@montefiore.org
William Chaplin
Latha Soorya
Stacey Wasserman
Sherry Novotny
Jade Rusoff
Nicole Feirsen
Lauren Pepa
Evdokia Anagnostou
Icahn School of Medicine at Mount Sinai · USChildren's Hospital at Montefiore · USSt. John's University · USUniversity of Toronto · CA

Funding

ZIPRASIDONE (GEODON) AUGMENTATION IN SEROTONIN REUPTAKE INHIBITOR-RESISTANT OBM01RR000071 · NCRR · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI NEWCORN, JEFFREY H · 1985 to 2009
$41.5M
Divalproex Sodium/Placebo In Child/Adolesent AutismR21NS043979 · NINDS · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI HOLLANDER, ERIC · 2001 to 2003
$509k
NCRR NIH HHS M01 RR000071NCRR NIH HHS MO1-RR00071NINDS NIH HHS R21 NS043979NINDS NIH HHS R21 NS43979-01
6 · The paper itself

Abstract

Autism spectrum disorders (ASDs) are neurodevelopmental disorders characterized by social and language deficits and by repetitive behaviors and interests. Irritability/aggression is a significant comorbid symptom in this population, which greatly impacts burden of care. This study examined the effect of divalproex sodium for irritability/aggression in children and adolescents with ASD. This was a 12-week randomized, double-blind, placebo-controlled trial. All efficacy measures were obtained by an independent evaluator blinded to randomization condition and side effects. A total of 55 subjects gavetheir consent and 27 were randomized in a 1 : 1 manner (mean age 9.46+/-2.46, mean nonverbal IQ 63.3+/-23.9). Two subjects from the active group and one subject from the placebo group discontinued the study because of either a lack of efficacy or side effects (increased irritability). Primary outcome measures were Aberrant Behavior Checklist-Irritability subscale and Clinical Global Impression-Improvement, which focused on irritability. Overall, 62.5% of divalproex subjects vs 9% of placebo subjects were responders (CGI-irritability OR: 16.7, Fisher's exact p=0.008). A statistically significant improvement was also noted on the ABC-Irritability subscale (p=0.048). There was a trend for responders to have higher valproate blood levels compared with nonresponders. This study suggests the efficacy of divalproex for the treatment of irritability in children and adolescents with ASD. Larger sample follow-up studies are warranted.

Indexed as

AdolescentAntimanic AgentsChildChild Behavior DisordersChild Development Disorders, PervasiveChild, PreschoolDouble-Blind MethodFemaleFollow-Up StudiesHumansIrritable MoodMalePersonality AssessmentPsychiatric Status Rating ScalesTreatment OutcomeValproic AcidAntimanic AgentsValproic Acid

Identifiers

PMID20010551
PMCPMC2846602
OpenAlexW2029331443

What OpenQuestion holds

Textmetadata
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.