Study · Randomized controlled trial · n = 290 · 2021

3 results

Intranasal Oxytocin in Children and Adolescents with Autism Spectrum Disorder.

Sikich L, Kolevzon A, King BH, McDougle CJ, Sanders KB, Kim SJ, Spanos M, Chandrasekhar T, Trelles MDP, Rockhill CM, Palumbo ML, Witters Cundiff A and 22 more

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Montgomery A, Siper P, Minjarez M, Nowinski LA, Marler S, Shuffrey LC, Alderman C, Weissman J, Zappone B, Mullett JE, Crosson H, Hong N, Siecinski SK, Giamberardino SN, Luo S, She L, Bhapkar M, Dean R, Scheer A, Johnson JL, Gregory SG, Veenstra-VanderWeele J

The New England journal of medicine1 Oct 2021Cited by 211 (Europe PMC)

PMID34644471PMCIDPMC9701092DOI10.1056/nejmoa2103583PepBankPUB-34644471

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children and adolescents with autism spectrum disorder, intranasal oxytocin did not change the ABC-mSW social withdrawal score more than placebo over 24 weeks.
In plain wordsIn children and teenagers with autism, oxytocin nasal spray did not improve social withdrawal scores more than placebo over 24 weeks.
Peptide
Oxytocin
Outcome
No significant changeChange in ABC-mSW social withdrawal score
Study
n = 277
Comparator
Placebo
Analysis
Primary
Outcome group
Autism core symptoms · Mental health and mood
Studied dose
48 international units daily (total target dose) · intranasal · 24 weeksAs given in this study (human).
Measurements
LS mean difference
−0.2 ABC-mSW points
oxytocin vs placebo
Source sentences
Summary
The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P = 0.61).
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder.
Summary · context
Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily.
Report a problemFND-3464447101
02HumanRandomized controlled trialEfficacy outcome
In children and adolescents with autism spectrum disorder, secondary outcomes generally did not differ between intranasal oxytocin and placebo.
In plain wordsIn children and teenagers with autism, secondary outcomes generally did not differ between oxytocin nasal spray and placebo.
Peptide
Oxytocin
Outcome
No significant changeSecondary social function and IQ outcomes
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
48 international units daily (total target dose) · intranasal · 24 weeksAs given in this study (human).
Source sentences
Summary
Secondary outcomes generally did not differ between the trial groups.
3 context sentences(design, population, supporting numbers)
Summary · context
Secondary outcomes included two additional measures of social function and an abbreviated measure of IQ.
Summary · context
We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder.
Summary · context
Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily.
Report a problemFND-3464447102
03HumanRandomized controlled trialSafety outcome
In children and adolescents with autism spectrum disorder, the incidence and severity of adverse events were similar with intranasal oxytocin and placebo.
In plain wordsIn children and teenagers with autism, side effects were similar with oxytocin nasal spray and with placebo.
Peptide
Oxytocin
Outcome
No significant changeIncidence and severity of adverse events
Study
n = 290
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
48 international units daily (total target dose) · intranasal · 24 weeksAs given in this study (human).
Source sentences
Summary
The incidence and severity of adverse events were similar in the two groups.
2 context sentences(design, population, supporting numbers)
Summary · context
We conducted a 24-week, placebo-controlled phase 2 trial of intranasal oxytocin therapy in children and adolescents 3 to 17 years of age with autism spectrum disorder.
Summary · context
Participants were randomly assigned in a 1:1 ratio, with stratification according to age and verbal fluency, to receive oxytocin or placebo, administered intranasally, with a total target dose of 48 international units daily.
Report a problemFND-3464447103

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT06945926

The Effect of Oxytocin Nasal Spray on Preventing Postoperative Delirium in Elderly Patients Undergoing Orthopedic Surgery

Zhejiang Universityn = 2271 Jun 2025 to 2 Jun 2026

Cervical Spinal Stenosis · Thoracic Spinal Stenosis · Lumbar Spinal Stenosis · Rotator Cuff Injury · Femoral Head Necrosis · Spinal Trauma · Knee Joint Injury

Trial page ClinicalTrials.govUpdated 20 Aug 2026

CompletedPhase 2Results postedNCT01944046

Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

Linmarie Sikichn = 2901 Aug 2014 to 30 Nov 2017

Autism Spectrum Disorders

Trial page ClinicalTrials.govUpdated 18 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 02:48 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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