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NCT03900754 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by VA Office of Research and Development.

Terminated
Registry status
Phase 2
Development phase
26
Enrollment target

NCT03900754: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.

NCT03900754 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03900754, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.

TERMINATED
Registry status
Phase 2
Development phase
26 participants
Enrollment target

Study 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. 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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Oxytocin

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2020-01-13
Est. Completion 2024-01-31
Phase Phase 2
VA Office of Research and Development

1,668 total trials

Why NCT03900754 stopped before completion

NCT03900754 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03900754 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03900754 about?

NCT03900754 is a clinical study titled "A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia". 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 ...

What is the current status of trial NCT03900754?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2020-01-13. Estimated completion is 2024-01-31.

What interventions are being tested in trial NCT03900754?

The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).

Who is sponsoring clinical trial NCT03900754?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03900754's enrollment target sits among peer trials

26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03900754, the US trial registry maintained by the National Library of Medicine. NCT03900754 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.