Trial · NCT01944046

Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors

NCT01944046, Phase 2, Completed, Linmarie Sikich; results first posted 2021-01-05

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors. Trials, record NCT01944046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01944046

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Trial

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

Title: Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors
NCT number: NCT01944046
Status: Completed
Phases: Phase 2
Enrollment: 290 participants, actual
Lead sponsor: Linmarie Sikich
Conditions: Autism Spectrum Disorders
Interventions: Double blind phase Placebo Nasal Spray, double Blind Oxytocin Nasal Spray, Open Label intranasal oxytocin
First posted: 2013-09-17
Last updated: 2021-06-18
Results first posted: 2021-01-05

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Least Mean Squares Double-blind phase: change from baseline to week 24	The primary outcome is Change in Aberrant Behavior Checklist-Modified Social Withdrawal subscale- a measure of reciprocal social behaviors. ABC-mSW is a modification of the ABC-Lethargy subscale. The ABC-mSW consists of the sum of questions 5,12,16, 20, 23, 26, 30, 37, 40, 42, 43, 55, and 58. In contrast to the ABC-Lethargy subscale it eliminates question 3 (listless, sluggish, inactive), question 32 (sits or stands in one position for a long time), and question 53 (inactive, never moves spontaneously). Thirteen individual items are scored 0-3, therefore the range is 0-39. Higher score indicates lower social reciprocity. Repeated measures were obtained at baseline, weeks 4, 8, 12, 16, 20, 24.
Primary	Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Least mean squares for Open Label: Change between weeks 24-48	The ABC-mSW is described above and involves 13 items reflecting lack of reciprocal interaction. Each item is scored from 0 (never shows behavior) to 3 (behavior is a major problem). The range is 0-39. Higher scores indicate worse reciprocal social functioning.
Secondary	Change in Sociability Factor (SF)	Double-blind phase: change in least means squares between week 0 & 24.	The Sociability Factor (SF) is a summed measure of the13 items of the ABC-SW and the 18 items of the Pervasive Development Disorders Behavior Inventory-Screening Version (PDDBI-SV).The PDDBI-SV assesses both adaptive social behaviors and social problems typical of ASD. The adaptive behaviors are reverse scored so that all the analyzed scores range from 0-performing in a neurotypical fashion to 3 typically performs in a way associated with ASD. the total # of items on this summed measure is 31 with a range from 0 to 93. More impaired social functioning indicated by higher scores. This measure was changed to a secondary outcome in the final statistical analysis plan.
Secondary	Change in Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score	Double-blind phase: baseline, weeks 12, 24	The SRS-Social Motivation subscale was developed to provide a quantitative measure of social impairments typically observed in ASD in children 3-18 years. Reported as T-score with a range of 38-90 for both boys and girls. Higher score indicates more severe clinical condition. Lower value in change indicates more improvement.
Secondary	Change in Stanford Binet-5th Edition (SB-5) IQ Score	Double-blind phase: baseline to week 24	Cognitive skills will be assessed using the Stanford Binet-5th Edition (SB-5) (Roid). Acceptable IQ range is 47-153, with higher score being better. Higher change scores indicate more improvement.
Other	Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score	Open Label: weeks 24, 48	The SRS-Social Motivation subscale was developed to provide a quantitative measure of social impairments typically observed in ASD in children 3-18 years. Reported as T-score with a range of 38-90 for both boys and girls. Higher score indicates more severe clinical condition. Lower value in change indicates more improvement.
Other	Change in Vineland II Adaptive Behavior Scales (VABS-II) Daily Living Domain Score	Double-blind phase: baseline, week 24; Open Label: week 48	Functional skills will be assessed using the VABS-II Daily Living Domain Score. Uses standard score with a mean of 100 and SD of 15 with a range of 20-160. Higher score is better. Higher value in change indicates more improvement.
Other	Caregiver Strain Questionnaire (CSQ) Subjective Internalizing Subscale Mean Score	Open Label: weeks 24, 48	Caregiver questionnaire that assesses the impact of caring for the proband on caregiver and family. Each item on the subjective internalizing CSQ subscale is rated from 1 to 5. Then all items within the subscale are summed and the mean is determined based on the number of items in the subscale. Higher score indicates more caregiver strain. Lower value in change indicates more improvement.
Other	Change in Vineland II Adaptive Behavior Scales (VABS-II) Communication Domain Score	Double-blind phase: baseline, week 24; Open Label: week 48	Functional skills will be assessed using the VABS-II Communication Domain Score. Uses standard score with a mean of 100 and SD of 15 with a range of 20-160. Higher score is better. Higher value in change indicates more improvement.
Other	Change in Caregiver Strain Questionnaire (CSQ) Subjective Internalizing Subscale Score	Double-blind phase: baseline, week 24	Caregiver questionnaire that assesses the impact of caring for the proband on caregiver and family. CSQ subscale scores are ranged from 1 to 5. with each item of the subscale having the same range, the sum of the items within the subscale are summed, and the mean score is determined (I.e. a single # between 1 and 5) and reported. Higher scores indicate more caregiver strain. Lower value in change indicates more improvement.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Least Mean Squares Double-blind phase: change from baseline to week 24	Full Analysis Set	score on a scale	MEAN
PRIMARY	Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Least mean squares for Open Label: Change between weeks 24-48	Open Label phase participants in OLE FAS excluding 2 participants without usable ABC-sws (either w24 or at least one pw24 ABC-sw.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Sociability Factor (SF)	Double-blind phase: change in least means squares between week 0 & 24.	Full Analysis Set	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score	Double-blind phase: baseline, weeks 12, 24	Full Analysis Set	T-score	MEAN
SECONDARY	Change in Stanford Binet-5th Edition (SB-5) IQ Score	Double-blind phase: baseline to week 24	Participants with scores collected at baseline and week 24.	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Social Responsiveness Scale-2 (SRS-2) Social Motivation Subscale Score	Open Label: weeks 24, 48	Open Label phase participants	T-score	MEAN
OTHER_PRE_SPECIFIED	Change in Vineland II Adaptive Behavior Scales (VABS-II) Daily Living Domain Score	Double-blind phase: baseline, week 24; Open Label: week 48	Full Analysis Set	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Caregiver Strain Questionnaire (CSQ) Subjective Internalizing Subscale Mean Score	Open Label: weeks 24, 48	Full Analysis Set participants who entered double blind and have values at week 24 AND 48	mean score on a scale	MEAN
OTHER_PRE_SPECIFIED	Change in Vineland II Adaptive Behavior Scales (VABS-II) Communication Domain Score	Double-blind phase: baseline, week 24; Open Label: week 48	Full Analysis Set	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Change in Caregiver Strain Questionnaire (CSQ) Subjective Internalizing Subscale Score	Double-blind phase: baseline, week 24	Full Analysis Set	score on a scale	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group74

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

Outcome	Group	Category	Value	Spread	Units
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Oxytocin Nasal Spray	Double-blind baseline to w4	8.81	Standard Error 0.39	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Placebo Nasal Spray	Double-blind baseline to w4	8.68	Standard Error 0.39	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Oxytocin Nasal Spray	Double-blind baseline to w8	8.97	Standard Error 0.45	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Placebo Nasal Spray	Double-blind baseline to w8	8.68	Standard Error 0.45	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Oxytocin Nasal Spray	Double-blind baseline-w12	7.48	Standard Error 0.43	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Placebo Nasal Spray	Double-blind baseline-w12	8.13	Standard Error 0.43	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Oxytocin Nasal Spray	DB w0- w16	7.99	Standard Error 0.46	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Placebo Nasal Spray	DB w0- w16	8.04	Standard Error 0.46	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Oxytocin Nasal Spray	DB w0- w20	7.81	Standard Error 0.05	score on a scale
Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity	Placebo Nasal Spray	DB w0- w20	7.75	Standard Error 0.45	score on a scale

1 to 10 of 74Source ClinicalTrials.gov

See all 74 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Randomized to DB	STARTED	Oxytocin Nasal Spray	146
Randomized to DB	STARTED	Placebo Nasal Spray	144
Randomized to DB	COMPLETED	Oxytocin Nasal Spray	125
Randomized to DB	COMPLETED	Placebo Nasal Spray	125
Randomized to DB	NOT COMPLETED	Oxytocin Nasal Spray	21
Randomized to DB	NOT COMPLETED	Placebo Nasal Spray	19
Open Label Eligible and Consented	STARTED	Oxytocin Nasal Spray	124
Open Label Eligible and Consented	STARTED	Placebo Nasal Spray	124
Open Label Eligible and Consented	COMPLETED	Oxytocin Nasal Spray	110
Open Label Eligible and Consented	COMPLETED	Placebo Nasal Spray	116

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events500

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	Negativism	Psychiatric disorders	Oxytocin Nasal Spray: Double-blind Phase	24	146
other	Negativism	Psychiatric disorders	Placebo Nasal Spray: Double-blind Phase	23	144
other	Negativism	Psychiatric disorders	Oxytocin Nasal Spray: Open Label Phase	10	127
other	Negativism	Psychiatric disorders	Placebo Nasal Spray: Open Label Phase	10	122
other	Aggression Or Hostility	Psychiatric disorders	Oxytocin Nasal Spray: Double-blind Phase	23	146
other	Aggression Or Hostility	Psychiatric disorders	Placebo Nasal Spray: Double-blind Phase	20	144
other	Aggression Or Hostility	Psychiatric disorders	Oxytocin Nasal Spray: Open Label Phase	10	127
other	Aggression Or Hostility	Psychiatric disorders	Placebo Nasal Spray: Open Label Phase	6	122
other	Anger Or Irritability	Psychiatric disorders	Oxytocin Nasal Spray: Double-blind Phase	20	146
other	Anger Or Irritability	Psychiatric disorders	Placebo Nasal Spray: Double-blind Phase	20	144

1 to 10 of 500Source ClinicalTrials.gov

See all 500 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxytocin Nasal Spray: Double-blind Phase	0	146
Total, all-cause mortality	Placebo Nasal Spray: Double-blind Phase	0	144
Total, all-cause mortality	Oxytocin Nasal Spray: Open Label Phase	1	127
Total, all-cause mortality	Placebo Nasal Spray: Open Label Phase	0	122
Total, other adverse events	Oxytocin Nasal Spray: Double-blind Phase	120	146
Total, other adverse events	Placebo Nasal Spray: Double-blind Phase	120	144
Total, other adverse events	Oxytocin Nasal Spray: Open Label Phase	91	127
Total, other adverse events	Placebo Nasal Spray: Open Label Phase	92	122
Total, serious adverse events	Oxytocin Nasal Spray: Double-blind Phase	2	146
Total, serious adverse events	Placebo Nasal Spray: Double-blind Phase	1	144

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32777383	BACKGROUND	PubMed
34644471	DERIVED	PubMed
37811711	DERIVED	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
U01HD073984	Study of Oxytocin in Autism to Improve Reciprocal Social Behaviors (SOARS-B)	SIKICH, LINMARIE	DUKE UNIVERSITY	EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT	2012 to 2016

Source NIH RePORTER

Trial comparisons0

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

None in this release.

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.

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