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Completed

NCT Number: NCT03245437

Target Engagement and Response to Oxytocin

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UCLA

Los Angeles, California, 90073, United States

About this study

The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Schizophrenia or schizoaffective disorder
  • stable on an antipsychotic medication

Exclusion criteria

  • positive pregnancy test history of head injury

Treatment and study plan

Oxytocin nasal spray

Drug

nasal spray

Other names: OT

Social Cognition Skills Training

Behavioral

Group based training in social cognition skills

Other names: SCST

Health Management

Behavioral

Group-based training in mental health management

Other names: HM

Placebo nasal spray

Drug

placebo condition

Other names: PBO

Primary outcomes

  1. Social Cognition Composite Score

    Time frame: 16 weeks

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

    Time frame: 16 weeks

    Standardized z-score

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2017
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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