Trial Outcomes & Findings for A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia (NCT NCT03900754)

Last Updated: 2026-01-20

Results Overview

The Social Functioning Scale is a 79-item semi-structured interview based assessment that includes \[a global summary score (primary outcome)\] The subscale scores of social engagement, interpersonal communication, and prosocial were expected the change in 3 weeks, while other subscales were not expected to change (e.g. employment) and thus were not collected during the chronic period. Scale ranges from 0 to lower functioning to 90 higher functioning.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

Baseline visit: Full assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: partial assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Results posted on

2026-01-20

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 fMRI phase: 2 fMRI scans - 20IU single administration oxytocin and placebo Chronic Phase: 20IU oxytocin for 3 weeks	Arm 2 fMRI phase (within subject): 2 fMRI scans - 20IU single administration oxytocin + placebo Chronic Phase: placebo for 3 weeks	Arm 3 fMRI phase: 2 fMRI scans - 40IU single administration oxytocin + placebo Chronic Phase: 40IU oxytocin for 3 weeks	Arm 4 fMRI phase: 2 fMRI scans - 40IU single administration oxytocin + placebo Chronic Phase: placebo for 3 weeks
Overall Study STARTED	7	4	9	6
Overall Study COMPLETED	2	2	6	3
Overall Study NOT COMPLETED	5	2	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 n=2 Participants fMRI phase: 20IU single administration oxytocin Chronic phase: 20IU oxytocin for 3 weeks	Arm 2 n=2 Participants fMRI phase: 20IU single administration oxytocin Chronic phase: placebo for 3 weeks	Arm 3 n=6 Participants fMRI phase: 40IU single administration oxytocin Chronic phase: 40IU oxytocin for 3 weeks	Arm 4 n=3 Participants fMRI phase: 40IU single administration oxytocin Chronic phase: placebo for 3 weeks	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=37 Participants	2 Participants n=44 Participants	6 Participants n=40 Participants	3 Participants n=121 Participants	13 Participants n=84 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Age, Continuous	57 years n=37 Participants	60 years n=44 Participants	51 years n=40 Participants	53 years n=121 Participants	54 years n=84 Participants
Sex: Female, Male Female	0 Participants n=37 Participants	1 Participants n=44 Participants	3 Participants n=40 Participants	1 Participants n=121 Participants	5 Participants n=84 Participants
Sex: Female, Male Male	2 Participants n=37 Participants	1 Participants n=44 Participants	3 Participants n=40 Participants	2 Participants n=121 Participants	8 Participants n=84 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Black or African American	2 Participants n=37 Participants	1 Participants n=44 Participants	4 Participants n=40 Participants	2 Participants n=121 Participants	9 Participants n=84 Participants
Race (NIH/OMB) White	0 Participants n=37 Participants	1 Participants n=44 Participants	2 Participants n=40 Participants	1 Participants n=121 Participants	4 Participants n=84 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	0 Participants n=44 Participants	0 Participants n=40 Participants	0 Participants n=121 Participants	0 Participants n=84 Participants
Region of Enrollment United States	2 Participants n=37 Participants	2 Participants n=44 Participants	6 Participants n=40 Participants	3 Participants n=121 Participants	13 Participants n=84 Participants

PRIMARY outcome

Timeframe: Baseline visit: Full assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: partial assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Population: Data for an individual was only included if both assessment timepoints were completed in full (i.e. no missing values)

Outcome measures

Outcome measures
Measure	Arm 2 n=2 Participants fMRI phase (within subject): 20IU single administration oxytocin Chronic Phase: placebo for 3 weeks	Arm 3 n=6 Participants fMRI phase: 40IU single administration oxytocin Chronic Phase: 40IU oxytocin for 3 weeks	Arm 4 n=3 Participants fMRI phase: 40IU single administration oxytocin Chronic Phase: placebo for 3 weeks	Arm 1 n=2 Participants fMRI phase: 20IU single administration oxytocin Chronic Phase: 20IU oxytocin for 3 weeks
Social Functioning Score Baseline	113.5 score on a scale Interval 112.0 to 115.0	79.2 score on a scale Interval 41.0 to 97.0	100 score on a scale Interval 74.0 to 115.0	102.5 score on a scale Interval 98.0 to 107.0
Social Functioning Score A1	30.5 score on a scale Interval 30.0 to 31.0	20.7 score on a scale Interval 14.0 to 37.0	20 score on a scale Interval 19.0 to 21.0	16 score on a scale Interval 13.0 to 19.0
Social Functioning Score A2	24 score on a scale Interval 19.0 to 29.0	21.3 score on a scale Interval 12.0 to 31.0	20 score on a scale Interval 14.0 to 30.0	14.5 score on a scale Interval 13.0 to 16.0

SECONDARY outcome

Timeframe: Baseline visit: assessment is collected prior to any treatments fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Population: Data for an individual was only included if the assessment was completed in full

Negative symptoms will be assessed with the CAINS (clinical assessment interview for negative symptoms) comprised of several subscales that will be summed for a global score. Each item is assessed from 0-no impairment to 4-severe deficit. The total score from 0 to 52 where higher scores represent more significant impairment.

Outcome measures

Outcome measures
Measure	Arm 2 n=2 Participants fMRI phase (within subject): 20IU single administration oxytocin Chronic Phase: placebo for 3 weeks	Arm 3 n=5 Participants fMRI phase: 40IU single administration oxytocin Chronic Phase: 40IU oxytocin for 3 weeks	Arm 4 n=3 Participants fMRI phase: 40IU single administration oxytocin Chronic Phase: placebo for 3 weeks	Arm 1 n=2 Participants fMRI phase: 20IU single administration oxytocin Chronic Phase: 20IU oxytocin for 3 weeks
CAINS Score (Clinical Assessment Interview for Negative Symptoms) Baseline	6 score on a scale Interval 5.0 to 7.0	16.4 score on a scale Interval 5.0 to 26.0	20.7 score on a scale Interval 9.0 to 41.0	21 score on a scale Interval 18.0 to 24.0
CAINS Score (Clinical Assessment Interview for Negative Symptoms) A1	10.5 score on a scale Interval 6.0 to 15.0	18.6 score on a scale Interval 4.0 to 31.0	16.7 score on a scale Interval 8.0 to 34.0	19 score on a scale Interval 14.0 to 24.0
CAINS Score (Clinical Assessment Interview for Negative Symptoms) A2	10.5 score on a scale Interval 7.0 to 14.0	17.2 score on a scale Interval 1.0 to 30.0	17 score on a scale Interval 0.0 to 36.0	19 score on a scale Interval 7.0 to 31.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Population: Data for an individual was only included if the assessment was completed in full

Quality of Life will be assessed with the Quality of Life Scale (QLS), a 9-item assessment that measures domains such as interpersonal relations, occupation role functioning, and intrapsychic foundations. Each item is rated from 0 to 6 with the lower values indicating greater severity of symptoms. As such, the total score ranges from 0-54 (higher scores indicate good quality of life).

Outcome measures

Outcome measures
Measure	Arm 2 n=2 Participants fMRI phase (within subject): 20IU single administration oxytocin Chronic Phase: placebo for 3 weeks	Arm 3 n=6 Participants fMRI phase: 40IU single administration oxytocin Chronic Phase: 40IU oxytocin for 3 weeks	Arm 4 n=3 Participants fMRI phase: 40IU single administration oxytocin Chronic Phase: placebo for 3 weeks	Arm 1 n=2 Participants fMRI phase: 20IU single administration oxytocin Chronic Phase: 20IU oxytocin for 3 weeks
QLS Scale (Quality of Life) A1	6 score on a scale Interval 4.0 to 8.0	2.6 score on a scale Interval 0.0 to 11.0	4.7 score on a scale Interval 1.0 to 10.0	2 score on a scale Interval 2.0 to 2.0
QLS Scale (Quality of Life) A2	5.5 score on a scale Interval 2.0 to 9.0	3 score on a scale Interval 0.0 to 12.0	3 score on a scale Interval 0.0 to 7.0	2 score on a scale Interval 1.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline visit: assessment not collected fMRI phase: assessment not collected Chronic phase: assessment collected before the start (A1) and at end (A2) of 3 weeks of daily administration

Population: Data for an individual was only included if the assessment was completed in full

Theory of Mind (ToM) will be assessed using The Hinting Task, a well-validated tool where participants make social inferences after hearing 10 fictional conversations. Each conversation ends with one character's utterance and the participant is asked to determine its meaning. Each item is scored from 0 to 2. The summed values of the scale from 0 to 20, where higher values represent better theory of mind / higher functioning