Trial · NCT01183221

The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders

NCT01183221, Phase 2, Completed, Alexander Kolevzon; results first posted 2021-04-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders. Trials, record NCT01183221. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183221

On this page

Trial

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

Title: The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
NCT number: NCT01183221
Status: Completed
Phases: Phase 2
Enrollment: 30 participants, actual
Lead sponsor: Alexander Kolevzon
Conditions: Autism, ASD
Interventions: Syntocinon, Placebo
First posted: 2010-08-17
Last updated: 2021-04-15
Results first posted: 2021-04-15

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Empathic Accuracy Performance	45 minutes after drug/placebo administration	Participants watch videos of targets describing positive and negative autobiographical events and provide continuous ratings of how positive-negative the target is feeling on a 9-point Likert scale. Empathic accuracy is operationalized as a timecourse correlation between perceiver inferences about target affect and targets' own affect ratings.
Primary	Fmri BOLD Response During Empathic Accuracy Task	45 minutes after oxytocin/placebo administration	Images will be acquired using a 3.0 Tesla Siemens Allegra MRI scanner equipped to acquire gradient-echo, echoplanar T2\*-weighted images (EPI) with blood oxygenation level dependent (BOLD) contrast. Each volume will comprise 26 axial slices of 4.5mm thickness and a 3.5 x 3.5mm in-plane resolution, aligned along the AC-PC axis. Volumes will be acquired continuously every 2 seconds. Each run will begin with 5 'dummy' volumes, which will be discarded from further analyses. At the end of the scanning session, a T-1 weighted structural image will be acquired from each participant.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Empathic Accuracy Performance	45 minutes after drug/placebo administration	The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points.
PRIMARY	Fmri BOLD Response During Empathic Accuracy Task	45 minutes after oxytocin/placebo administration	The computer in the imaging suite crashed and the behavioral outcome data were not adequately backed up. The imaging data cannot be analyzed while pts were performing the EA task because without the behavioral data, the researchers do not know what pts were doing at each timepoint (it was an event related design). The researchers would not have the necessary information to know how to segment the data or what trial type (self/other/control) pts were doing at the various time points.

Source ClinicalTrials.gov

Results by group0

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

None in this release.

Participant flow18

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

Period	Milestone	Group	Participants
First Dose	STARTED	Syntocinon Then Placebo	15
First Dose	STARTED	Placebo Then Syntocinon	15
First Dose	COMPLETED	Syntocinon Then Placebo	15
First Dose	COMPLETED	Placebo Then Syntocinon	15
First Dose	NOT COMPLETED	Syntocinon Then Placebo	0
First Dose	NOT COMPLETED	Placebo Then Syntocinon	0
3 Weeks Wash Out	STARTED	Syntocinon Then Placebo	15
3 Weeks Wash Out	STARTED	Placebo Then Syntocinon	15
3 Weeks Wash Out	COMPLETED	Syntocinon Then Placebo	14
3 Weeks Wash Out	COMPLETED	Placebo Then Syntocinon	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events40

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	Ringing Ears	Ear and labyrinth disorders	Syntocinon	0	28
other	Ringing Ears	Ear and labyrinth disorders	Placebo	1	28
other	Headache	General disorders	Syntocinon	4	28
other	Headache	General disorders	Placebo	2	28
other	Fatigue	General disorders	Syntocinon	2	28
other	Fatigue	General disorders	Placebo	1	28
other	Shortness of Breath	Respiratory, thoracic and mediastinal disorders	Syntocinon	1	28
other	Shortness of Breath	Respiratory, thoracic and mediastinal disorders	Placebo	0	28
other	Watery eyes	Endocrine disorders	Syntocinon	1	28
other	Watery eyes	Endocrine disorders	Placebo	2	28

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Syntocinon	0	28
Total, all-cause mortality	Placebo	0	28
Total, other adverse events	Syntocinon	8	28
Total, other adverse events	Placebo	10	28
Total, serious adverse events	Syntocinon	0	28
Total, serious adverse events	Placebo	0	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Syntocinon vs Placebo: deaths from any cause	Trial comparisons
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/NCT01183221

GET https://conductscience.org/api/trials/v1/NCT01183221/events?page=2

API reference For AI assistants