Target Engagement and Response to Oxytocin
Primary Purpose
Schizophrenia
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxytocin nasal spray
Social Cognition Skills Training
Health Management
Placebo nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Social Cognition, Oxytocin
Eligibility Criteria
Inclusion Criteria:
- Schizophrenia or schizoaffective disorder
- stable on an antipsychotic medication
Exclusion Criteria:
- positive pregnancy test history of head injury
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Sham Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Oxytocin with SCST
Oxytocin with Health Management
Placebo with SCST
Placebo with HM
Arm Description
Oxytocin with SCST (active condition)
Administration of OT with control psychosocial treatment
Administration of Placebo with active psychosocial treatment
Administration of Placebo with control psychosocial treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
Standardized z-score
Full Information
NCT ID
NCT03245437
First Posted
August 7, 2017
Last Updated
July 11, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03245437
Brief Title
Target Engagement and Response to Oxytocin
Official Title
Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
December 4, 2023 (Anticipated)
Study Completion Date
December 4, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Social Cognition, Oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind Placebo controlled
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin with SCST
Arm Type
Experimental
Arm Description
Oxytocin with SCST (active condition)
Arm Title
Oxytocin with Health Management
Arm Type
Sham Comparator
Arm Description
Administration of OT with control psychosocial treatment
Arm Title
Placebo with SCST
Arm Type
Placebo Comparator
Arm Description
Administration of Placebo with active psychosocial treatment
Arm Title
Placebo with HM
Arm Type
Placebo Comparator
Arm Description
Administration of Placebo with control psychosocial treatment
Intervention Type
Drug
Intervention Name(s)
Oxytocin nasal spray
Other Intervention Name(s)
OT
Intervention Description
nasal spray
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition Skills Training
Other Intervention Name(s)
SCST
Intervention Description
Group based training in social cognition skills
Intervention Type
Behavioral
Intervention Name(s)
Health Management
Other Intervention Name(s)
HM
Intervention Description
Group-based training in mental health management
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Other Intervention Name(s)
PBO
Intervention Description
placebo condition
Primary Outcome Measure Information:
Title
Social Cognition Composite Score
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
Description
Standardized z-score
Time Frame
16 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia or schizoaffective disorder
stable on an antipsychotic medication
Exclusion Criteria:
positive pregnancy test history of head injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Marder, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
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Target Engagement and Response to Oxytocin
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