Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Target Engagement and Response to Oxytocin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245437
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Stephen R. Marder, University of California, Los Angeles

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.

Layout table for study information
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 : May 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245437


Contacts
Layout table for location contacts
Contact: Gerard DeVera 310-478-3711 ext 44932 Gdevera@mednet.ucla.edu
Contact: Stephen Marder, MD 3102683647 ext 3102683647 marder@ucla.edu

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Stephen Marder, MD University of California, Los Angeles
Layout table for additonal 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    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021

Layout table for additional information
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:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs