SchizophreniaPhase 2NCT03900754
A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia
A Phase 2 study testing Oxytocin in people with Schizophrenia, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jan 2020to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
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.
Read the detailed description
The study uses a combined within- and between-subject placebo-controlled study design.
Within subjects phase: After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco-fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. Following the fMRI phase of the study, participants will be randomized for the next phase of the study
Between subjects phase: Participants will receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks. Before and after the three weeks of drug administration, participants will be assessed for social functioning, social ability, negative symptoms, and theory of mind. More participants will be randomized to receive chronically administered oxytocin than placebo to maximize the study's power to test the investigators' hypothesis that acute oxytocin-induced increases in right temporo-parietal junction activity will be positively correlated with improvements in social functioning (primary outcome), social ability, negative symptoms, and theory of mind over three weeks of oxytocin administration.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin, Placebo
- Keywords
- Oxytocin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
Intranasal administration of oxytocin
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Oxytocin | Experimental | Dosages of oxytocin: 20IU or 40IU. Receives: Drug: Oxytocin |
| Placebo | Placebo comparator | Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Functioning Score
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.
Measured: 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
Secondary outcomes (1)
CAINS Score (Clinical Assessment Interview for Negative Symptoms)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start13 Jan 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: Inadequate Subject Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study uses a combined within- and between-subject placebo-controlled study design. After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. 75 participants will be randomized to receive 20IU oxytocin and placebo and 75 will be randomized to receive 40IU oxytocin and placebo, with the order of administration randomized and separated by two weeks. Following the fMRI phase of the study, participants will be randomized to receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Francisco, VA Greater Los Angeles Healthcare System
- Responsible party
- Sponsor
- Investigators
- Josh Woolley, BS, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900754
- Sponsor's protocol ID
- MHBB-011-18F
- Other IDs
- 19-27265, 1I01CX001761-01A2
- Status last verified
- Dec 2025
- First submitted
- 1 Apr 2019
- Last updated
- 20 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia
- ClinicalTrials.gov ID
- NCT03900754
- Acronym / sponsor ID
- MHBB-011-18F
- Conditions
- Schizophrenia
- Keywords
- Oxytocin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate Subject Recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of California, San Francisco, VA Greater Los Angeles Healthcare System
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Posted 20 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study uses a combined within- and between-subject placebo-controlled study design.
Within subjects phase: After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco-fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. Following the fMRI phase of the study, participants will be randomized for the next phase of the study
Between subjects phase: Participants will receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks. Before and after the three weeks of drug administration, participants will be assessed for social functioning, social ability, negative symptoms, and theory of mind. More participants will be randomized to receive chronically administered oxytocin than placebo to maximize the study's power to test the investigators' hypothesis that acute oxytocin-induced increases in right temporo-parietal junction activity will be positively correlated with improvements in social functioning (primary outcome), social ability, negative symptoms, and theory of mind over three weeks of oxytocin administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study uses a combined within- and between-subject placebo-controlled study design. After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. 75 participants will be randomized to receive 20IU oxytocin and placebo and 75 will be randomized to receive 40IU oxytocin and placebo, with the order of administration randomized and separated by two weeks. Following the fMRI phase of the study, participants will be randomized to receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intranasal Oxytocin | Experimental | Drug: OxytocinDosages of oxytocin: 20IU or 40IU. |
| Placebo | Placebo comparator | Drug: PlaceboSaline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: SyntocinonIntranasal administration of oxytocin | Drug | Intranasal Oxytocin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh Woolley, BS principal investigator
San Francisco VA Medical Center, San Francisco, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxytocin in people with Schizophrenia, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.