Target Engagement and Response to Oxytocin

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03245437
• Other study ID #: OT R33
• Secondary ID: R33MH107564
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 4, 2018
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Schizophrenia or schizoaffective disorder
• stable on an antipsychotic medication

Exclusion Criteria:

• positive pregnancy test history of head injury

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Oxytocin nasal spray
nasal spray

Behavioral:
• Social Cognition Skills Training
Group based training in social cognition skills
• Health Management
Group-based training in mental health management

Drug:
• Placebo nasal spray
placebo condition

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social Cognition Composite Score	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	Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery	Standardized z-score	16 weeks