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| ID | Type | Description | Link |
|---|---|---|---|
| R33MH107564 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin with SCST | Experimental | Oxytocin with SCST (active condition) |
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| Oxytocin with Health Management | Sham Comparator | Administration of OT with control psychosocial treatment |
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| Placebo with SCST | Placebo Comparator | Administration of Placebo with active psychosocial treatment |
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| Placebo with HM | Placebo Comparator | Administration of Placebo with control psychosocial treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin nasal spray | Drug | nasal spray |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery | Standardized z-score | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Marder, MD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90073 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 15, 2025 | Jan 6, 2026 | 10 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Double-Blind Placebo controlled
| Social Cognition Skills Training | Behavioral | Group based training in social cognition skills |
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| Health Management | Behavioral | Group-based training in mental health management |
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| Placebo nasal spray | Drug | placebo condition |
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