Target Engagement and Response to Oxytocin

Phase 4

Active, not recruiting

• Conditions: Schizophrenia
• Interventions: Drug: Oxytocin nasal spray; Behavioral: Health Management; Drug: Placebo nasal spray; Behavioral: Social Cognition Skills Training

• Registration Number: NCT03245437
• Lead Sponsor: University of California, Los Angeles

Brief 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.

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 Timeline

• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-10
• Study Start: 2018-01-04
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Schizophrenia or schizoaffective disorder
• stable on an antipsychotic medication

Read More

Exclusion Criteria

• positive pregnancy test history of head injury

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin with SCST	Oxytocin nasal spray	Oxytocin with SCST (active condition)
Oxytocin with Health Management	Health Management	Administration of OT with control psychosocial treatment
Placebo with SCST	Placebo nasal spray	Administration of Placebo with active psychosocial treatment
Placebo with HM	Placebo nasal spray	Administration of Placebo with control psychosocial treatment
Oxytocin with SCST	Social Cognition Skills Training	Oxytocin with SCST (active condition)
Oxytocin with Health Management	Oxytocin nasal spray	Administration of OT with control psychosocial treatment
Placebo with SCST	Social Cognition Skills Training	Administration of Placebo with active psychosocial treatment
Placebo with HM	Health Management	Administration of Placebo with control psychosocial treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery	16 weeks	Standardized z-score

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States