Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
Overview
- Phase
- Phase 4
- Intervention
- Oxytocin nasal spray
- Conditions
- Schizophrenia
- Sponsor
- University of California, Los Angeles
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Social Cognition Composite Score
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Stephen R. Marder
Professor
University of California, Los Angeles
Eligibility Criteria
Inclusion Criteria
- •Schizophrenia or schizoaffective disorder
- •stable on an antipsychotic medication
Exclusion Criteria
- •positive pregnancy test history of head injury
Arms & Interventions
Oxytocin with SCST
Oxytocin with SCST (active condition)
Intervention: Oxytocin nasal spray
Oxytocin with SCST
Oxytocin with SCST (active condition)
Intervention: Social Cognition Skills Training
Oxytocin with Health Management
Administration of OT with control psychosocial treatment
Intervention: Oxytocin nasal spray
Oxytocin with Health Management
Administration of OT with control psychosocial treatment
Intervention: Health Management
Placebo with SCST
Administration of Placebo with active psychosocial treatment
Intervention: Social Cognition Skills Training
Placebo with SCST
Administration of Placebo with active psychosocial treatment
Intervention: Placebo nasal spray
Placebo with HM
Administration of Placebo with control psychosocial treatment
Intervention: Health Management
Placebo with HM
Administration of Placebo with control psychosocial treatment
Intervention: Placebo nasal spray
Outcomes
Primary Outcomes
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
- Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery(16 weeks)