Schizophrenia
Conditions
Keywords
Social Cognition, Oxytocin
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.
Interventions
DRUGOxytocin nasal spray
nasal spray
BEHAVIORALSocial Cognition Skills Training
Group based training in social cognition skills
BEHAVIORALHealth Management
Group-based training in mental health management
DRUGPlacebo nasal spray
placebo condition
Sponsors
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blind Placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Schizophrenia or schizoaffective disorder * stable on an antipsychotic medication
Exclusion criteria
* positive pregnancy test history of head injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery | 16 weeks | Standardized z-score |
Countries
United States
Outcome results
None listed