Trial · NCT01962870

The Role of Vasopressin in the Social Deficits of Autism

NCT01962870, Phase 2, Completed, Stanford University; results first posted 2019-05-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Role of Vasopressin in the Social Deficits of Autism. Trials, record NCT01962870. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01962870

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Trial

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

Title: The Role of Vasopressin in the Social Deficits of Autism
NCT number: NCT01962870
Status: Completed
Phases: Phase 2
Enrollment: 68 participants, actual
Lead sponsor: Stanford University
Conditions: Autism Spectrum Disorders
Interventions: Vasopressin, Placebo
First posted: 2013-10-14
Last updated: 2019-05-24
Results first posted: 2019-05-24
Limitations and caveats: The final sample was 83% male and was not statistically powered to detect sex differences in treatment response. Participants were permitted to take other medications during the intervention. Many of our outcome measures relied on parent report.

Source ClinicalTrials.gov

Registered outcomes21

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.	Baseline; Week 4	Social Responsiveness Scale, 2nd Edition (SRS) scores measure social abilities with lower scores meaning better social abilities. (T-Score Range: 37- above 90 )
Secondary	Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment.	Baseline; Week 4	Higher Scores on the CGI severity scale mean more greater social and communication deficits (Range 1-7)
Secondary	Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.	Baseline; Week 4	Higher scores mean better ability to read emotions and lower scores mean worse ability to read emotions. Range 0-28.
Secondary	Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.	Baseline; Week 4	Higher scores mean better facial emotion recognition abilities. Lower scores mean worse facial emotion recognition abilities (Range: 0-42).
Secondary	Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.	Baseline; Week 4	Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)
Secondary	Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.	Baseline; Week 4	Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)
Secondary	Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment	Baseline through Week 4	Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.
Secondary	Change From Baseline on the Overt Aggression Scale (OAS) During Treatment.	Baseline through Week 4	Count of participants reporting an increase of aggression during treatment compared to baseline (pretreatment).
Secondary	Change From Baseline in Heart Rate After Treatment.	Baseline; Week 4	Sitting heart rate (beats per minute).
Secondary	Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.	Baseline; Week 4	Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.	Baseline; Week 4	Participants who completed the protocol are included in the analysis.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment.	Baseline; Week 4	Participants with available data are included.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.	Baseline; Week 4	Participants with available data are included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.	Baseline; Week 4	Participants with available data are included in the analysis.	units on a scale	MEAN
SECONDARY	Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.	Baseline; Week 4	Participants with available data were analyzed.	units on a scale	MEAN
SECONDARY	Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.	Baseline; Week 4	Participants with available data were analyzed.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment	Baseline through Week 4	Participants who completed the protocol are included in the analysis.	participants	NUMBER
SECONDARY	Change From Baseline on the Overt Aggression Scale (OAS) During Treatment.	Baseline through Week 4	Participants with available data are included in the analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Heart Rate After Treatment.	Baseline; Week 4	Participants who completed the protocol are included in the analysis.	Beats per minute	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Parent Rated Aberrant Behavior Checklist (ABC) Scores During Treatment.	Baseline; Week 4	Participants with available data were included in analysis.	units on a scale	MEAN

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group128

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.	Placebo	10.8	Standard Error 2.11	units on a scale
Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment.	Vasopressin	17.6	Standard Error 1.37	units on a scale
Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment.	Placebo	0.712	Standard Error 0.202	units on a scale
Change From Baseline in Clinical Global Impression (CGI) Severity, Social and Communication Scores During Treatment.	Vasopressin	0.873	Standard Error 0.126	units on a scale
Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.	Placebo	-1.28	Standard Error 1.24	units on a scale
Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.	Vasopressin	4.04	Standard Error 1.63	units on a scale
Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.	Placebo	-7.19	Standard Error 1.81	units on a scale
Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.	Vasopressin	3.10	Standard Error 2.42	units on a scale
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.	Placebo	21.3	Standard Error 3.18	units on a scale
Change From Baseline in Parent Rated Repetitive Behavior Scale Revised (RBS-R) Scores During Treatment.	Vasopressin	17.2	Standard Error 1.83	units on a scale

1 to 10 of 128Source ClinicalTrials.gov

See all 128 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	13
Overall Study	STARTED	Vasopressin	17
Overall Study	COMPLETED	Placebo	13
Overall Study	COMPLETED	Vasopressin	17
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Vasopressin	0

Source ClinicalTrials.gov

Adverse events62

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	Fever	General disorders	Placebo	1	13
other	Fever	General disorders	Vasopressin	2	17
other	Cough	General disorders	Placebo	0	13
other	Cough	General disorders	Vasopressin	1	17
other	Body Ache	General disorders	Placebo	0	13
other	Body Ache	General disorders	Vasopressin	1	17
other	Excitement/Agitation	Psychiatric disorders	Placebo	1	13
other	Excitement/Agitation	Psychiatric disorders	Vasopressin	4	17
other	Insomnia	Nervous system disorders	Placebo	1	13
other	Insomnia	Nervous system disorders	Vasopressin	4	17

1 to 10 of 62Source ClinicalTrials.gov

See all 62 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	13
Total, all-cause mortality	Vasopressin	0	17
Total, other adverse events	Placebo	12	13
Total, other adverse events	Vasopressin	13	17
Total, serious adverse events	Placebo	0	13
Total, serious adverse events	Vasopressin	0	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37811711	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21MH100387	The role of vasopressin in the social deficits of autism	PARKER, KAREN J.; HARDAN, ANTONIO	STANFORD UNIVERSITY	NATIONAL INSTITUTE OF MENTAL HEALTH	2013 to 2014

Source NIH RePORTER

Trial comparisons3

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

Comparison	Source
Vasopressin vs Placebo: Change From Baseline on the Overt Aggression Scale (OAS) During Treatment.	Trial comparisons
Vasopressin vs Placebo: deaths from any cause	Trial comparisons
Vasopressin 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/NCT01962870

GET https://conductscience.org/api/trials/v1/NCT01962870/registered?page=2

API reference For AI assistants