Trial · NCT02824627

Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders

NCT02824627, Phase 2, Completed, University of Nebraska; results first posted 2022-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders. Trials, record NCT02824627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02824627

On this page

Trial

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

Title: Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders
NCT number: NCT02824627
Status: Completed
Phases: Phase 2
Enrollment: 58 participants, actual
Lead sponsor: University of Nebraska
Conditions: Mood Disorder, Disruptive Behavior Disorders
Interventions: Oxytocin, Placebo
First posted: 2016-07-06
Last updated: 2023-10-05
Results first posted: 2022-08-30

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Change in Affective Reactivity Index - Youth (ARI-Y)	baseline and 21 days	The Affective Reactivity Index-Youth (ARI-Y) is a 7 item inventory (youth self-report) specifically designed to measure irritability and emotional dysregulation as a dimensional construct across psychopathologies in children and adolescents (Stringaris et al., 2012). ARI scores range from 0 to 12. Total scores are reported. Higher scores are indicative of more (worse) irritability. We report the change in ARI-Y score as our outcome measure.
Primary	Clinical Global Impression: Severity	21 days (study endpoint)	The Clinical Global Impression: Severity scale is a single-item clinician rated measure of the clinician's impression of the degree of illness of the subject in terms of level of irritability from study start to endpoint. Ratings are 1=normal, not ill, 2= borderline ill, 3= minimally ill, 4= moderately ill, 5= markedly ill, 6= severely ill; 7= very severely ill. A single score of 1 to 7 is given at study endpoint for each subject. A higher score indicates worsening of the subject's irritability based on clinician impression.
Secondary	Functional MRI (fMRI) BOLD Response Changes	baseline and 21 days	percent change in BOLD response from baseline to study end point

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Affective Reactivity Index - Youth (ARI-Y)	baseline and 21 days		score on a scale	MEAN
PRIMARY	Clinical Global Impression: Severity	21 days (study endpoint)		score on a scale	MEAN
SECONDARY	Functional MRI (fMRI) BOLD Response Changes	baseline and 21 days	Number of participants who completed 2 scans (baseline and at the end of the study).	mean percent change	MEAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Change in Affective Reactivity Index - Youth (ARI-Y)	Oxytocin	-2.9	Standard Deviation 2.3	score on a scale
Change in Affective Reactivity Index - Youth (ARI-Y)	Placebo	-0.8	Standard Deviation 2.5	score on a scale
Clinical Global Impression: Severity	Oxytocin	2.72	Standard Deviation 0.79	score on a scale
Clinical Global Impression: Severity	Placebo	3.33	Standard Deviation 1.07	score on a scale
Functional MRI (fMRI) BOLD Response Changes	Oxytocin	-0.045	Standard Deviation 0.007	mean percent change
Functional MRI (fMRI) BOLD Response Changes	Placebo	0.045	Standard Deviation 0.009	mean percent change

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxytocin	28
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Oxytocin	25
Overall Study	COMPLETED	Placebo	27
Overall Study	NOT COMPLETED	Oxytocin	3
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events18

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	Events
other	Drowsiness	General disorders	Oxytocin	9	25	9
other	Drowsiness	General disorders	Placebo	6	27	6
other	Headache	Nervous system disorders	Oxytocin	3	25	3
other	Headache	Nervous system disorders	Placebo	8	27	8
other	Sleep Disturbance	Psychiatric disorders	Oxytocin	2	25	2
other	Sleep Disturbance	Psychiatric disorders	Placebo	0	27	0
other	Dizziness	Nervous system disorders	Oxytocin	1	25	1
other	Dizziness	Nervous system disorders	Placebo	1	27	1
other	Mood Changes	Psychiatric disorders	Oxytocin	3	25	3
other	Mood Changes	Psychiatric disorders	Placebo	8	27	8

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxytocin	0	25
Total, all-cause mortality	Placebo	0	27
Total, other adverse events	Oxytocin	21	25
Total, other adverse events	Placebo	25	27
Total, serious adverse events	Oxytocin	0	25
Total, serious adverse events	Placebo	0	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34288223	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 comparisons2

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

Comparison	Source
Oxytocin vs Placebo: deaths from any cause	Trial comparisons
Oxytocin 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/NCT02824627

GET https://conductscience.org/api/trials/v1/NCT02824627/registered

API reference For AI assistants