Effect of a novel nasal oxytocin spray with enhanced bioavailability on autism: a randomized trial.

Yamasue H, Kojima M, Kuwabara H, Kuroda M, Matsumoto K, Kanai C, Inada N, Owada K, Ochi K, Ono N, Benner S, Wakuda T and 29 more

Show all authors

Kameno Y, Inoue J, Harada T, Tsuchiya K, Umemura K, Yamauchi A, Ogawa N, Kushima I, Ozaki N, Suyama S, Saito T, Uemura Y, Hamada J, Kano Y, Honda N, Kikuchi S, Seto M, Tomita H, Miyoshi N, Matsumoto M, Kawaguchi Y, Kanai K, Ikeda M, Nakamura I, Isomura S, Hirano Y, Onitsuka T, Kosaka H, Okada T

Brain : a journal of neurology1 Apr 2022Cited by 44 (Europe PMC)

PMID35067719DOI10.1093/brain/awab291PepBankPUB-35067719

Source link PubMedAsk about this study

Jump to 4 results

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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adult males with autism, TTA-121 oxytocin spray 6 U/day did not significantly reduce the ADOS reciprocity score versus placebo in the full analysis set.
In plain wordsIn men with autism, an oxytocin nasal spray at 6 U/day did not clearly lower the social reciprocity score compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeADOS reciprocity score, 6 U/day versus placebo (full analysis set)
Study
n = 109
Comparator
Placebo
Analysis
Primary
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
6 U/day · intranasal · 4 weeksAs given in this study (human).
Measurements
mean difference
−0.5 ADOS reciprocity points
full analysis set
Source sentences
Summary
The Autism Diagnostic Observation Schedule reciprocity score, the primary outcome, was reduced in the TTA-121 6 U/day administration period compared with the placebo (full analysis set: P = 0.118, mean difference = -0.5; 95% CI: -1.1 to 0.1; per protocol set: P = 0.012, mean difference = -0.8; 95% CI: -1.3 to -0.2).
2 context sentences(design, population, supporting numbers)
Summary · context
Four-week administrations of TTA-121, at low dose once per day (3 U/day), low dose twice per day (6 U/day), high dose once per day (10 U/day), or high dose twice per day (20 U/day), and 4-week placebo were administered in a crossover manner.
Summary · context
Of 109 males with high-functioning autism spectrum disorder who were randomized, 103 completed the trial.
Report a problemFND-3506771901
02HumanRandomized controlled trialEfficacy outcome
In adult males with autism, TTA-121 oxytocin spray 6 U/day reduced the ADOS reciprocity score versus placebo in the per protocol set.
In plain wordsIn men with autism who followed the protocol, an oxytocin nasal spray at 6 U/day lowered the social reciprocity score more than placebo.
Peptide
Oxytocin
Outcome
DecreaseADOS reciprocity score, 6 U/day versus placebo (per protocol set)
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
6 U/day · intranasal · 4 weeksAs given in this study (human).
Measurements
mean difference
−0.8 ADOS reciprocity points
per protocol set
Source sentences
Summary
The Autism Diagnostic Observation Schedule reciprocity score, the primary outcome, was reduced in the TTA-121 6 U/day administration period compared with the placebo (full analysis set: P = 0.118, mean difference = -0.5; 95% CI: -1.1 to 0.1; per protocol set: P = 0.012, mean difference = -0.8; 95% CI: -1.3 to -0.2).
2 context sentences(design, population, supporting numbers)
Summary · context
Four-week administrations of TTA-121, at low dose once per day (3 U/day), low dose twice per day (6 U/day), high dose once per day (10 U/day), or high dose twice per day (20 U/day), and 4-week placebo were administered in a crossover manner.
Summary · context
Of 109 males with high-functioning autism spectrum disorder who were randomized, 103 completed the trial.
Report a problemFND-3506771902
03HumanRandomized controlled trialEfficacy outcome
In adult males with autism, none of the secondary clinical and behavioural outcomes improved significantly with TTA-121 versus placebo in the full analysis set.
In plain wordsIn men with autism, an oxytocin nasal spray did not significantly improve any secondary outcome compared with placebo.
Peptide
Oxytocin
Outcome
No significant changeSecondary clinical and behavioural outcomes
Study
n = 109
Comparator
Placebo
Analysis
Secondary
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
3-20 U/day · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
None of the secondary clinical and behavioural outcomes were significantly improved with the TTA-121 compared with the placebo in the full analysis set.
2 context sentences(design, population, supporting numbers)
Summary · context
Four-week administrations of TTA-121, at low dose once per day (3 U/day), low dose twice per day (6 U/day), high dose once per day (10 U/day), or high dose twice per day (20 U/day), and 4-week placebo were administered in a crossover manner.
Summary · context
Of 109 males with high-functioning autism spectrum disorder who were randomized, 103 completed the trial.
Report a problemFND-3506771904
04HumanRandomized controlled trialEfficacy outcome
In adult males with autism, the dose-response contrast peaked at 6 U/day with an inverted U shape, without a significant P value.
In plain wordsIn men with autism, oxytocin nasal spray seemed to work best at 6 U/day, but this was not statistically clear.
Peptide
Oxytocin
Outcome
MixedDose-response relationship of TTA-121
Study
n: not reported in source
Outcome group
Social behavior and cognition · Mental health and mood
Studied dose
3-20 U/day · intranasal · 4 weeksAs given in this study (human).
Source sentences
Summary
The smallest P-value, judged as the dose-response relationship, was the contrast with the peak at TTA-121 6 U/day, with inverted U-shape for both the full analysis set (P = 0.182) and per protocol set (P = 0.073).
3 context sentences(design, population, supporting numbers)
Summary · context
A novel intranasal spray of oxytocin with enhanced bioavailability enabled us to test a wide range of multiple doses, revealing an inverted U-shape dose-response curve, with the peak at a dose that was lower than expected from previous studies.
Summary · context
Four-week administrations of TTA-121, at low dose once per day (3 U/day), low dose twice per day (6 U/day), high dose once per day (10 U/day), or high dose twice per day (20 U/day), and 4-week placebo were administered in a crossover manner.
Summary · context
Of 109 males with high-functioning autism spectrum disorder who were randomized, 103 completed the trial.
Report a problemFND-3506771903

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

Registered trials1

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

1 trial · source ClinicalTrials.gov (opens in a new tab)

Status unknownPhase 2NCT03466671

A Trial of TTA-121 on Autism Spectrum Disorder

Hamamatsu Universityn = 14427 Feb 2018 to est. 30 Mar 2020

Autism Spectrum Disorder

Trial page ClinicalTrials.govUpdated 20 Dec 2019

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.