Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT03900754Other idMHBB-011-18FOther id19-27265Other id1I01CX001761-01A2

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Inadequate Subject Recruitment

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 26 participants (actual)
Sponsor: VA Office of Research and Development · Fed
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 13 Jan 2020
Primary completion: 31 Jan 2024
Completion: 31 Jan 2024
First posted: 3 Apr 2019
Last update posted: 20 Jan 2026
Conditions: Schizophrenia

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202020212022202320242025

Ph 2
A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia
NCT03900754
13 Jan 2020 to 31 Jan 2024
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population. Some of the most disabling symptoms, such as low motivation, difficulty expressing emotions, and decreased ability to infer the mental states of others, cause poor social functioning. This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community. Unfortunately, current antipsychotic medications typically only improve positive symptoms but fail to improve social functioning deficits, which are strong predictors of poor quality of life and functional outcomes. Oxytocin, a peptide found in the brain, plays an important role in social behavior and is known to moderate affiliation, stress, and learning across taxa. In this study, the investigators will test whether oxytocin could be an effective treatment for social functioning deficits in schizophrenia. The investigators will examine changes in brain activation to understand how oxytocin affects behavior and to predict which individuals may benefit from oxytocin treatment.

Interventions

OxytocinDrug
PlaceboDrug

Arms2

Experimental
Intranasal Oxytocin
Dosages of oxytocin: 20IU or 40IU.
Placebo comparator
Placebo
Saline

Primary outcomes1

Outcomes the sponsor listed as primary.

Social Functioning Score
Time frame · 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
Registry description
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.

Secondary outcomes(1)

CAINS Score (Clinical Assessment Interview for Negative Symptoms)
Time frame · 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
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

Social Functioning Score

Group	Value (score on a scale)
Arm 1	102.5
Arm 2	113.5
Arm 3	79.2
Arm 4	100

Secondary and other outcome results(3)

Secondary outcomeMean· 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

CAINS Score (Clinical Assessment Interview for Negative Symptoms)

Group	Value (score on a scale)
Arm 1	21
Arm 2	6
Arm 3	16.4
Arm 4	20.7

Other pre specified outcomeMean· 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

QLS Scale (Quality of Life)

Group	Value (score on a scale)
Arm 1	2
Arm 2	6
Arm 3	2.6
Arm 4	4.7

Hinting Task

Group	Value (score on a scale)
Arm 1	19
Arm 2	16
Arm 3	14.8
Arm 4	17.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Arm 1 fMRI PhasefMRI phase: 20IU single administration oxytocin	0 / 2	0 / 2	0 / 2
Arm 2 fMRI PhasefMRI phase: 20IU single administration oxytocin	0 / 2	0 / 2	0 / 2
Arm 3 fMRI PhasefMRI phase: 40IU single administration oxytocin	0 / 6	0 / 6	1 / 6
Arm 4 fMRI PhasefMRI phase: 40IU single administration oxytocin	0 / 3	0 / 3	0 / 3
Arm 1 Chronic PhaseChronic Phase: 20IU oxytocin for 3 weeks	0 / 2	0 / 2	0 / 2
Arm 2 Chronic PhaseChronic Phase: placebo for 3 weeks	0 / 2	0 / 2	0 / 2
Arm 3 Chronic PhaseChronic Phase: 40IU oxytocin for 3 weeks	0 / 6	0 / 6	1 / 6
Arm 4 Chronic PhaseChronic Phase: placebo for 3 weeks	0 / 3	0 / 3	0 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Veteran * age 18-70 * a diagnosis of schizophrenia, schizophreniform, schizoaffective, or brief psychotic disorder determined by the Structured Clinical Interview for DSM-5 * no medication changes or psychiatric hospitalizations in the past month * SFS modified raw score of no more than 75 Exclusion Criteria: * substance use disorder in the past month, except mild to moderate cannabis use disorder * illness affecting the nasal passages * significant neurological/medical disorder * pacemakers * extensive dental work * claustrophobia * deafness * inability to read * currently participating in a psychosocial intervention targeting social functioning deficits * currently taking high dose testosterone or estrogen/progesterone * inability to complete VOT

PepBank is a research reference. Talk to a doctor before you use any peptide.