Target Engagement and Response to Oxytocin

NCT03245437 — Phase 4, Completed, 120 participants, University of California, Los Angeles

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

Registry	NCT03245437
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	120 (Actual)
Sponsor	University of California, Los Angeles (Other); collaborators: National Institute of Mental Health (NIMH)
Conditions	Schizophrenia
Interventions	Oxytocin nasal spray, Social Cognition Skills Training, Health Management, Placebo nasal spray (Drug, behavioral)
Dates	start 2018-01-04, primary completion 2024-07-31, completion 2024-07-31, first posted 2017-08-10, last updated 2025-03-21
Locations	1 site in United States

-Summary

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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Oxytocin with SCST	Experimental	Drug: Oxytocin nasal spray; Behavioral: Social Cognition Skills Training	Oxytocin with SCST (active condition)
Oxytocin with Health Management	Sham comparator	Drug: Oxytocin nasal spray; Behavioral: Health Management	Administration of OT with control psychosocial treatment
Placebo with SCST	Placebo comparator	Behavioral: Social Cognition Skills Training; Drug: Placebo nasal spray	Administration of Placebo with active psychosocial treatment
Placebo with HM	Placebo comparator	Behavioral: Health Management; Drug: Placebo nasal spray	Administration of Placebo with control psychosocial treatment

Oxytocin nasal spray (Drug), also known as OT: nasal spray
Social Cognition Skills Training (Behavioral), also known as SCST: Group based training in social cognition skills
Health Management (Behavioral), also known as HM: Group-based training in mental health management
Placebo nasal spray (Drug), also known as PBO: placebo condition

+Outcome measures

Primary outcomes

Social Cognition Composite Score [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

Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery [16 weeks]: Standardized z-score

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* stable on an antipsychotic medication

Exclusion Criteria:

* positive pregnancy test history of head injury

+Locations (1)

Facility	City	Country	Status
UCLA	Los Angeles, California	United States

+Investigators

Stephen Marder, MD, Principal investigator, University of California, Los Angeles

+Funding

NIH grants: R33MH107564

My Notes

Public

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