Trial · NCT01028677

Oxytocin Treatment of Schizophrenia

NCT01028677, Not applicable, Completed, University of North Carolina, Chapel Hill; results first posted 2017-04-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oxytocin Treatment of Schizophrenia. Trials, record NCT01028677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01028677

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Trial

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

Title: Oxytocin Treatment of Schizophrenia
NCT number: NCT01028677
Status: Completed
Phases: Not applicable
Enrollment: 17 participants, actual
Lead sponsor: University of North Carolina, Chapel Hill
Conditions: Paranoia, Schizophrenia, Schizoaffective Disorder
Interventions: intranasal spray with oxytocin, nasal spray without oxytocin
First posted: 2009-12-09
Last updated: 2017-04-18
Results first posted: 2017-04-18

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	6 weeks	The Emotion Recognition-40 (ER-40; Kohler, Turner, Gur, \& Gur, 2004) consists of a series of 40 faces, shown one at a time on a computer screen. Participants choose the correct emotions based on 5 answer choices: happy, sad, anger, fear and no emotion. Participants indicate the word that best describes the emotion each faces expresses. The stimuli are presented in a randomized order each time they are administered. A scoring program automatically records accuracy and median response time. Range for each emotion (score range) is 0 (no correct responses) to 8 (all faces on each emotion category are correctly identified). The ER-40 faces were derived from the University of Pennsylvania Emotion Recognition Task, 96 faces version, and are balanced for equality and intensity of emotion, age, gender and ethnicity.
Primary	Theory of Mind as Measured by the Eyes Test at 6 Weeks	6 weeks	The Eyes Test (Baron-Cohen, Wheelwright, Hill, Raste, \& Plumb, 2001) consists of 36 photographs where participants are asked to guess the mental state (i.e., what the person is thinking or feeling) from among four choice words. Participants are given a practice item to ensure that they understand the task. Each eye region is displayed on a computer screen with the four choice mental states shown in the four corners of the computer screen (one target word and three foil words). The score range is 0 (no correct responses) to 36 (all stimuli are correctly identified).
Primary	Theory of Mind as Measured by the Brune Test at 6 Weeks	6 weeks	In The Brune Test (Brune, 2003), participants are shown a series of six sets of four cartoon pictures that illustrate interactions between two or more individuals. The cartoon cards were displayed to the participant in a predetermined scrambled order. Participants are asked to rearrange the pictures in an order that conveys a logical story. After the participant arranges the cards, the examiner ensures they are in the correct sequence. If they are not in the correct order, the examiner silently arranges them so they are in the logical sequence.The participant's interpretations of the characters' beliefs are scored as correct or incorrect (zero or one), with higher scores indicating better Theory of Mind. The sum of correct answers is the outcome of interest. The participants can receive a maximum total of 23 points for the questions.
Primary	Social Perception as Measured by the Trustworthiness Task at 6 Weeks	6 weeks	The Trustworthiness Task (Adolphs, Tranel, \& Damasio, 1998) is comprised of 42 black and white photographs of the faces of unfamiliar people. Participants are shown each picture individually (on a computer monitor) and asked to rate how much they would trust that person (e.g., with their money) on a seven-point scale, ranging from -3 (very untrustworthy) to +3 (very trustworthy). They are provided with a photograph of 0 or an average face (i.e., someone they would neither trust nor distrust) to refer to throughout the task (based on Adolphs et al.'s, 1998 norms). The total score is the sum of the trustworthiness ratings. Possible range is -126 to 126.
Primary	Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks	6 weeks	The Interpersonal Reactivity Index (IRI; Davis, 1983) is a self-report measure of cognitive and affective empathy. The IRI consists of 28 items where participants rate how well each item describes them using a five-point scale (1 to 5). The 28 items yield four subscales: perspective taking (PT), empathic concern (EC), fantasy (F), and personal distress (PD). Higher scores indicate a greater empathic response. Score range for IRI: min, max Total: 28, 140 PT: 7, 35 EC: 7, 35 F: 7, 35 PD: 7, 35
Secondary	Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks	6 weeks	The PANSS consists of 30 items (7 positive psychotic symptoms, 7 negative psychotic symptoms, 16 general psychopathology symptoms) on which subjects are rated (1-7) based upon a semi-standardized interview. Higher scores indicate more/greater symptoms (i.e., greater symptoms of psychosis) and lower scores indicate fewer symptoms (better outcome). Possible score range: min, max Total: 30,210 Positive symptoms:7, 49 Negative symptoms:7, 49 General symptoms: 16,112

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	6 weeks	number of correct responses	MEAN
SECONDARY	Clinical Psychiatric Symptoms as Measured by Positive and Negative Syndrome Scale (PANSS) at 6 Weeks	6 weeks	rating on a scale	MEAN
PRIMARY	Theory of Mind as Measured by the Eyes Test at 6 Weeks	6 weeks	correct responses	MEAN
PRIMARY	Theory of Mind as Measured by the Brune Test at 6 Weeks	6 weeks	correct responses	MEAN
PRIMARY	Social Perception as Measured by the Trustworthiness Task at 6 Weeks	6 weeks	rating on a scale	MEAN
PRIMARY	Empathy as Measured by the Interpersonal Reactivity Index (IRI) at 6 Weeks	6 weeks	rating on a scale	MEAN

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray With Oxytocin	Fear	7.25	Standard Deviation .89	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray Without Oxytocin	Fear	6.67	Standard Deviation 1.86	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray With Oxytocin	Anger	4.38	Standard Deviation 1.30	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray Without Oxytocin	Anger	6.17	Standard Deviation 1.72	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray With Oxytocin	Sad	7.13	Standard Deviation 1.46	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray Without Oxytocin	Sad	6.50	Standard Deviation 1.64	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray With Oxytocin	Happy	8.00	Standard Deviation .00	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray Without Oxytocin	Happy	7.83	Standard Deviation .41	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray With Oxytocin	Neutral	7.25	Standard Deviation .89	number of correct responses
Emotion Recognition as Measured by the Emotion Recognition-40 at the 6 Week Time Point	Intranasal Spray Without Oxytocin	Neutral	7.17	Standard Deviation .98	number of correct responses

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intranasal Spray With Oxytocin	10
Overall Study	STARTED	Intranasal Spray Without Oxytocin	7
Overall Study	COMPLETED	Intranasal Spray With Oxytocin	8
Overall Study	COMPLETED	Intranasal Spray Without Oxytocin	6
Overall Study	NOT COMPLETED	Intranasal Spray With Oxytocin	2
Overall Study	NOT COMPLETED	Intranasal Spray Without Oxytocin	1

Source ClinicalTrials.gov

Adverse events4

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	low blood pressure due to blood-draw	Vascular disorders	Intranasal Spray With Oxytocin	1	10	1
other	low blood pressure due to blood-draw	Vascular disorders	Intranasal Spray Without Oxytocin	0	7	0
serious	Serious Adverse Events	Psychiatric disorders	Intranasal Spray With Oxytocin	0	10	0
serious	Serious Adverse Events	Psychiatric disorders	Intranasal Spray Without Oxytocin	0	7	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intranasal Spray With Oxytocin
Total, all-cause mortality	Intranasal Spray Without Oxytocin
Total, other adverse events	Intranasal Spray With Oxytocin	1	10
Total, other adverse events	Intranasal Spray Without Oxytocin	0	7
Total, serious adverse events	Intranasal Spray With Oxytocin	0	10
Total, serious adverse events	Intranasal Spray Without Oxytocin	0	7

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 comparisons1

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

Comparison
Intranasal Spray With Oxytocin vs Intranasal Spray Without Oxytocin: serious adverse events

Source Trial comparisons

Tests1

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

Test	Named as
Emoji Emotion Recognition	Primary outcome

Source ConductCognition

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/NCT01028677

GET https://conductscience.org/api/trials/v1/NCT01028677/results?page=2

API reference For AI assistants