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Trial · Interventional

CompletedPhase 4Registry data

Target Engagement and Response to Oxytocin

NCTNCT03245437 (opens ClinicalTrials.gov in a new tab)Other idOT R33Other idR33MH107564
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
120 participants (actual)
Sponsor
University of California, Los Angeles · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
4 Jan 2018
Primary completion
31 Jul 2024
Completion
31 Jul 2024
First posted
10 Aug 2017
Last update posted
21 Mar 2025
Conditions
Schizophrenia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018202020222024
  1. Ph 4

    Target Engagement and Response to Oxytocin

    NCT03245437

    4 Jan 2018 to 31 Jul 2024

Registry summary

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

This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

Interventions

  • Oxytocin nasal sprayDrug
  • Social Cognition Skills TrainingBehavioral
  • Health ManagementBehavioral
  • Placebo nasal sprayDrug

Arms4

  • Experimental

    Oxytocin with SCST

    Oxytocin with SCST (active condition)

  • Sham comparator

    Oxytocin with Health Management

    Administration of OT with control psychosocial treatment

  • Placebo comparator

    Placebo with SCST

    Administration of Placebo with active psychosocial treatment

  • Placebo comparator

    Placebo with HM

    Administration of Placebo with control psychosocial treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Social Cognition Composite Score

    Time frame · 16 weeks

    Registry description

    We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure.

Secondary outcomes(1)

  1. Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery

    Time frame · 16 weeks

    Registry description

    Standardized z-score

Posted results

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

No results are posted for this trial.

Completed trials do not always post results.

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 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Schizophrenia or schizoaffective disorder * stable on an antipsychotic medication Exclusion Criteria: * positive pregnancy test history of head injury

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