Target Engagement and Response to Oxytocin

March 19, 2025 updated by: Stephen R. Marder, University of California, Los Angeles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Schizophrenia or schizoaffective disorder
  • stable on an antipsychotic medication

Exclusion Criteria:

  • positive pregnancy test history of head injury

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin with SCST
Oxytocin with SCST (active condition)
Drug: Oxytocin nasal spray
nasal spray
Other Names:
  • OT
Behavioral: Social Cognition Skills Training
Group based training in social cognition skills
Other Names:
  • SCST
Sham Comparator: Oxytocin with Health Management
Administration of OT with control psychosocial treatment
Drug: Oxytocin nasal spray
nasal spray
Other Names:
  • OT
Behavioral: Health Management
Group-based training in mental health management
Other Names:
  • HM
Placebo Comparator: Placebo with SCST
Administration of Placebo with active psychosocial treatment
Behavioral: Social Cognition Skills Training
Group based training in social cognition skills
Other Names:
  • SCST
Drug: Placebo nasal spray
placebo condition
Other Names:
  • PBO
Placebo Comparator: Placebo with HM
Administration of Placebo with control psychosocial treatment
Behavioral: Health Management
Group-based training in mental health management
Other Names:
  • HM
Drug: Placebo nasal spray
placebo condition
Other Names:
  • PBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
Time Frame: 16 weeks
Standardized z-score
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Stephen Marder, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2018

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

August 7, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OT R33
  • R33MH107564 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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