Target Engagement and Response to Oxytocin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin nasal spray
* Behavioral: Social Cognition Skills Training
* Behavioral: Health Management
* Drug: Placebo nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Schizophrenia or schizoaffective disorder stable on an antipsychotic medication Exclusion Criteria: positive pregnancy test history of head injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin with SCST<br>Oxytocin with SCST (active condition) | Drug: Oxytocin nasal spray<br>* nasal spray<br>* Other names: OT;Behavioral: Social Cognition Skills Training<br>* Group based training in social cognition skills<br>* Other names: SCST;|
| Sham Comparator: Oxytocin with Health Management<br>Administration of OT with control psychosocial treatment | Drug: Oxytocin nasal spray<br>* nasal spray<br>* Other names: OT;Behavioral: Health Management<br>* Group-based training in mental health management<br>* Other names: HM;|
| Placebo Comparator: Placebo with SCST<br>Administration of Placebo with active psychosocial treatment | Behavioral: Social Cognition Skills Training<br>* Group based training in social cognition skills<br>* Other names: SCST;Drug: Placebo nasal spray<br>* placebo condition<br>* Other names: PBO;|
| Placebo Comparator: Placebo with HM<br>Administration of Placebo with control psychosocial treatment | Behavioral: Health Management<br>* Group-based training in mental health management<br>* Other names: HM;Drug: Placebo nasal spray<br>* placebo condition<br>* Other names: PBO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery | Standardized z-score | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Cognition, Oxytocin