Evidence map›Paper›PMID 27552585›Full record

Trial reportTranslational psychiatry2016

Oxytocin efficacy is modulated by dosage and oxytocin receptor genotype in young adults with high-functioning autism: a 24-week randomized clinical trial.

H Kosaka, Y Okamoto, T Munesue, H Yamasue, K Inohara, T Fujioka, T Anme, M Orisaka, M Ishitobi, M Jung and 12 more

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Translational psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 3 pooled it
18.8field-weighted citation impact, top 1% 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

51 citing papers in PubMed, 3 syntheses or guidelines pooled it, 119 citations in OpenAlex.

  1. Pooled it
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  13. Oxytocin and its links through scientific lineage.Comprehensive psychoneuroendocrinology · 2024
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  19. Oxytocin administration versus emotion training in healthy males: considerations for future research.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2022
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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

22 authors at 6 institutions in 1 country.

H KosakaResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
Y OkamotoResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
T MunesueResearch Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.
H YamasueDepartment of Neuropsychiatry, School of Medicine, University of Tokyo, Tokyo, Japan.
K InoharaDepartment of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui, Eiheiji, Japan.
T FujiokaDepartment of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui, Eiheiji, Japan.
T AnmeInternational Community Care and Lifespan Development, Empowerment Sciences, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
M OrisakaDepartment of Obstetrics and Gynecology, University of Fukui, Eiheiji, Japan.
M IshitobiDepartment of Neuropsychiatry, Faculty of Medical Sciences, University of Fukui, Eiheiji, Japan.
M JungResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
T X FujisawaResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
S TanakaResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
S AraiResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
M AsanoResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
D N SaitoResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
N SadatoDepartment of Cerebral Research, National Institute for Physiological Sciences, Okazaki, Japan.
A TomodaResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
M OmoriFaculty of Nursing and Social Welfare Sciences, Fukui Prefectural University, Eiheiji, Japan.
M SatoResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
H OkazawaResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.ORCID 0000-0001-7046-3383
H HigashidaResearch Center for Child Mental Development, Kanazawa University, Kanazawa, Japan.
Y WadaResearch Center for Child Mental Development, University of Fukui, Eiheiji, Japan.
Kanazawa University · JPUniversity of Fukui · JPFukui Prefectural University · JPNational Institute for Physiological Sciences · JPThe University of Tokyo · JPUniversity of Tsukuba · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recent studies have suggested that long-term oxytocin administration can alleviate the symptoms of autism spectrum disorder (ASD); however, factors influencing its efficacy are still unclear. We conducted a single-center phase 2, pilot, randomized, double-blind, placebo-controlled, parallel-group, clinical trial in young adults with high-functioning ASD, to determine whether oxytocin dosage and genetic background of the oxytocin receptor affects oxytocin efficacy. This trial consisted of double-blind (12 weeks), open-label (12 weeks) and follow-up phases (8 weeks). To examine dose dependency, 60 participants were randomly assigned to high-dose (32 IU per day) or low-dose intranasal oxytocin (16 IU per day), or placebo groups during the double-blind phase. Next, we measured single-nucleotide polymorphisms (SNPs) in the oxytocin receptor gene (OXTR). In the intention-to-treat population, no outcomes were improved after oxytocin administration. However, in male participants, Clinical Global Impression-Improvement (CGI-I) scores in the high-dose group, but not the low-dose group, were significantly higher than in the placebo group. Furthermore, we examined whether oxytocin efficacy, reflected in the CGI-I scores, is influenced by estimated daily dosage and OXTR polymorphisms in male participants. We found that >21 IU per day oxytocin was more effective than ⩽21 IU per day, and that a SNP in OXTR (rs6791619) predicted CGI-I scores for ⩽21 IU per day oxytocin treatment. No severe adverse events occurred. These results suggest that efficacy of long-term oxytocin administration in young men with high-functioning ASD depends on the oxytocin dosage and genetic background of the oxytocin receptor, which contributes to the effectiveness of oxytocin treatment of ASD.

Indexed as

Administration, IntranasalAdolescentAdultAutism Spectrum DisorderAutistic DisorderDouble-Blind MethodFemaleGenotypeHumansMaleOxytocicsOxytocinPolymorphism, Single NucleotideReceptors, OxytocinSex FactorsTreatment OutcomeOXTR protein, humanOxytocicsOxytocinReceptors, Oxytocin

Identifiers

PMID27552585
PMCPMC5022092
OpenAlexW2514199772

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.