Evidence map›Paper›PMID 26659550›Full record

Trial reportJournal of autism and developmental disorders2016

Lurasidone for the Treatment of Irritability Associated with Autistic Disorder.

Antony Loebel, Matthew Brams, Robert S Goldman, Robert Silva, David Hernandez, Ling Deng, Raymond Mankoski, Robert L Findling

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

Trial report in Journal of autism and developmental disorders, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 7 pooled it
3.3field-weighted citation impact, top 8% 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

24 citing papers in PubMed, 7 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
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  7. Harms of Antipsychotics in Children and Young Adults: A Systematic Review Update.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2018
    Pooled it
  8. Trial
  9. Review
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  16. Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder.Journal of autism and developmental disorders · 2021
    Article
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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

8 authors at 4 institutions in 1 country.

Antony LoebelSunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA.
Matthew BramsMenninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA.
Robert S GoldmanSunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA.
Robert SilvaSunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA.
David HernandezSunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA.
Ling DengSunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA.
Raymond MankoskiSunovion Pharmaceuticals, Inc., Fort Lee, NJ, USA. Raymond.Mankoski@Sunovion.com.
Robert L FindlingChild and Adolescent Psychiatry, Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD, USA.
Sunovion (United States) · USVion Pharmaceuticals (United States) · USBaylor College of Medicine · USJohns Hopkins University · US

Funding

Translational Neuroscience CoreU54HD079123 · NICHD · HUGO W. MOSER RES INST KENNEDY KRIEGER · PI FATEMI, S. ALI, SCHLAGGAR, BRADLEY L · 2014 to 2019
$7.9M
NICHD NIH HHS U54 HD079123
6 · The paper itself

Abstract

The aim of this study was to evaluate the short-term efficacy and safety of lurasidone in treating irritability associated with autistic disorder. In this multicenter trial, outpatients age 6-17 years who met DSM-IV-TR criteria for autistic disorder, and who demonstrated irritability, agitation, and/or self-injurious behaviors were randomized to 6 weeks of double-blind treatment with lurasidone 20 mg/day (N = 50), 60 mg/day (N = 49), or placebo (N = 51). Efficacy measures included the Aberrant Behavior Checklist Irritability subscale (ABC-I, the primary endpoint) and the Clinical Global Impressions, Improvement (CGI-I) scale, and were analyzed using a likelihood-based mixed model for repeated measures. Least squares (LS) mean (standard error [SE]) improvement from baseline to Week 6 in the ABC-I was not significantly different for lurasidone 20 mg/day (-8.8 [1.5]) and lurasidone 60 mg/day (-9.4 [1.4]) versus placebo (-7.5 [1.5]; p = 0.55 and 0.36, respectively). CGI-I scores showed significantly greater LS mean [SE] improvement at Week 6 for lurasidone 20 mg/day versus placebo (2.8 [0.2] vs. 3.4 [0.2]; p = 0.035) but not for lurasidone 60 mg/day (3.1 [0.2]; p = 0.27). Discontinuation rates due to adverse events were: lurasidone 20 mg/day, 4.1%; 60 mg/day, 3.9%; and placebo, 8.2%. Adverse events with an incidence ≥10% (lurasidone combined, placebo) included vomiting (18.0, 4.1%) and somnolence (12.0, 4.1%). Modest changes were observed in weight and selected metabolic parameters. In this study, once-daily, fixed doses of 20 and 60 mg/day of lurasidone were not demonstrated to be efficacious compared to placebo for the short-term treatment of children and adolescents with moderate-to-severe irritability associated with autistic disorder.

Indexed as

Irritable MoodAdolescentAntipsychotic AgentsAutistic DisorderChildFemaleHumansLurasidone HydrochlorideMaleAntipsychotic AgentsLurasidone HydrochlorideAtypical antipsychoticAutismIrritabilityLurasidone

Identifiers

PMID26659550
PMCPMC4786592
OpenAlexW2193951151

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.