Target Engagement and Response to Oxytocin

• ClinicalTrials.gov Identifier: NCT03245437
• Recruitment Status: Recruiting
• First Posted: August 10, 2017
• Last Update Posted: September 6, 2022
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Stephen R. Marder, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Oxytocin nasal spray; Behavioral: Social Cognition Skills Training; Behavioral: Health Management; Drug: Placebo nasal spray	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double-Blind Placebo controlled
• Primary Purpose: Treatment
• Official Title: Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
• Actual Study Start Date: January 4, 2018
• Estimated Primary Completion Date: February 4, 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery [ Time Frame: 16 weeks ]
   Standardized z-score

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Schizophrenia or schizoaffective disorder
• stable on an antipsychotic medication

Exclusion Criteria:

• positive pregnancy test history of head injury

Contacts and Locations

Contacts

Contact: Gerard DeVera; 310-478-3711 ext 44932; Gdevera@mednet.ucla.edu

Contact: Stephen Marder, MD; 3102683647 ext 3102683647; marder@ucla.edu

Locations

United States, California

UCLA; Recruiting

Los Angeles, California, United States, 90073

Contact: Stephen R Marder, MD 310-268-3647 marder@ucla.edu

Contact: Robert S Kern, PhD 3104783711 ext 49229 rkern@ucla.edu

Principal Investigator: Stephen R Marder, MD

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Stephen Marder, MD; University of California, Los Angeles

More Information

• Responsible Party: Stephen R. Marder, Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03245437
• Other Study ID Numbers: OT R33
• First Posted: August 10, 2017
• Last Update Posted: September 6, 2022
• Last Verified: September 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephen R. Marder, University of California, Los Angeles:

Social Cognition; Oxytocin

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs