Trial · NCT01908205

Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)

NCT01908205, Phase 2, Completed, Holland Bloorview Kids Rehabilitation Hospital; results first posted 2020-11-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD). Trials, record NCT01908205. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01908205

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Intranasal Oxytocin for the Treatment of Children and Adolescents With Autism Spectrum Disorders (ASD)
NCT number: NCT01908205
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Conditions: Autism Spectrum Disorder
Interventions: Intranasal Oxytocin, Placebo
First posted: 2013-07-25
Last updated: 2025-07-16
Results first posted: 2020-11-16
Limitations and caveats: Limitations include a small sample size, age range restricted to 10-17, and IQ restriction of 70+. This limits our ability to generalize our results to other individuals on the autism spectrum.

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	12 and 24 weeks	This will be measured by a change in score on the Aberrant Behavior Checklist (ABC) - Social Withdrawal Subscale (0-48, where lower scores indicate improvement)
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	12 Weeks	This will be measured by a change in score the Revised Eyes Test (0- 28; where higher scores indicate better performance/improvement) Baseline to Week 12
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	12 Weeks	This will be measured by improvement on the Let's Face it! Skills Battery from Baseline to Week 12 Social Cognition (higher score=better outcome) a. Let's Face It Skills Battery; i. Matchmaker (0-100); ii. Faces (0-100); iii. Houses (0-100)
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	12 Weeks	This will be measured by improvement on the Behavioral Assessment System for Children (BASC-2) from Baseline to Week 12 Behavioral Assessment System for Children (higher score=positive response); i. \Social Skills: age 6 to 11 (18-69); age 12 to 17 (21-70); ii. Functional Communication: age 6 to 11 (10-66); age 12 to 17 (10-64); iii. Withdrawal age 6-11 (21- 62) ; age 12-17 (14-42) \ only social subscales of BASC-2 reported
Secondary	Number of Participant Considered Social Responders	12 Weeks	This will be measured by the Clinical Global Impressions - Improvement Scale - Social (CGI-I-Social) a) Clinical Global Impressions - Social Scale (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as a social responder (achieving a score of 1 or 2 on the scale).
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors	12 Weeks	This will be measured by improvement on the Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) from Baseline to Week 12 -lower score= positive response (0-20)
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors	12 Weeks	This will be measured by improvement on the Repetitive Behavior Scale (RBS-R)(0-129; where lower score= positive response) from Baseline to Week 12
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety	12 Weeks	This will be measured by the Child and Adolescent Symptom Inventory (CASI-4R) Generalized anxiety score (male (40-101); female (41-96) -where lower score= positive response) from Baseline to Week 12
Secondary	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life	12 Weeks	This will be measured by improvement on the Pediatric Quality of Life Inventory (PedsQL) (0-100, where higher scores indicate positive response) from Baseline to Week 12
Secondary	Number of Participant Considered Overall Responders	12 Weeks	This will be measured by the Clinical Global Impressions - Improvement Scale - Global (CGI-I-Global) (1-7) (lower score=positive response). The results will be reported as the number of participants that were classified as an overall responder (achieving a score of 1 or 2 on the scale).

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	12 and 24 weeks	units on a scale	MEAN
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	12 Weeks	score on a scale	MEAN
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	12 Weeks	units on a scale	MEAN
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	12 Weeks	score on a scale	MEAN
SECONDARY	Number of Participant Considered Social Responders	12 Weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors	12 Weeks	units on a scale	MEAN
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Repetitive Behaviors	12 Weeks	units on a scale	MEAN
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Anxiety	12 Weeks	units on a scale	MEAN
SECONDARY	Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Quality of Life	12 Weeks	score on a scale	MEAN
SECONDARY	Number of Participant Considered Overall Responders	12 Weeks	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group42

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	Intranasal Oxytocin	Baseline - Week 12	-2.43	95% Confidence Interval -5.06 to 0.21	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	Placebo	Baseline - Week 12	-3.06	95% Confidence Interval -5.28 to -0.84	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	Intranasal Oxytocin	Baseline- Week 24	-1.34	95% Confidence Interval -4.22 to 1.55	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function	Placebo	Baseline- Week 24	-3.03	95% Confidence Interval -5.60 to -0.47	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	Intranasal Oxytocin		0.14	95% Confidence Interval -1.57 to 1.30	score on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	Placebo		-0.29	95% Confidence Interval -1.58 to 1.00	score on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	Intranasal Oxytocin	Let's Face It Matchmaker	4.50	95% Confidence Interval -0.29 to 9.28	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	Placebo	Let's Face It Matchmaker	5.90	95% Confidence Interval 2.22 to 9.59	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	Intranasal Oxytocin	Let's Face It Faces	6.20	95% Confidence Interval 2.96 to 9.45	units on a scale
Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Cognition	Placebo	Let's Face It Faces	1.52	95% Confidence Interval -2.41 to 5.45	units on a scale

1 to 10 of 42Source ClinicalTrials.gov

See all 42 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Intranasal Oxytocin (Syntocinon)	30
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Intranasal Oxytocin (Syntocinon)	25
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	Intranasal Oxytocin (Syntocinon)	5
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events214

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Lymphadenopathy	Blood and lymphatic system disorders	Intranasal Oxytocin (Syntocinon)	0	30
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo	1	30
other	Palpitations	Cardiac disorders	Intranasal Oxytocin (Syntocinon)	1	30
other	Palpitations	Cardiac disorders	Placebo	0	30
other	Ear congestion	Ear and labyrinth disorders	Intranasal Oxytocin (Syntocinon)	0	30
other	Ear congestion	Ear and labyrinth disorders	Placebo	1	30
other	Ear discomfort	Ear and labyrinth disorders	Intranasal Oxytocin (Syntocinon)	1	30
other	Ear discomfort	Ear and labyrinth disorders	Placebo	0	30
other	Ear pain	Ear and labyrinth disorders	Intranasal Oxytocin (Syntocinon)	1	30
other	Ear pain	Ear and labyrinth disorders	Placebo	0	30

1 to 10 of 214Source ClinicalTrials.gov

See all 214 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intranasal Oxytocin (Syntocinon)	0	30
Total, all-cause mortality	Placebo	0	30
Total, other adverse events	Intranasal Oxytocin (Syntocinon)	28	30
Total, other adverse events	Placebo	25	30
Total, serious adverse events	Intranasal Oxytocin (Syntocinon)	0	30
Total, serious adverse events	Placebo	0	30

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37811711	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intranasal Oxytocin vs Placebo: Number of Participant Considered Overall Responders	Trial comparisons
Intranasal Oxytocin vs Placebo: Number of Participant Considered Social Responders	Trial comparisons
Intranasal Oxytocin (Syntocinon) vs Placebo: deaths from any cause	Trial comparisons
Intranasal Oxytocin (Syntocinon) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01908205

GET https://conductscience.org/api/trials/v1/NCT01908205/results?page=2

API reference For AI assistants