Target Engagement and Response to Oxytocin

NCT03245437 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: OT R33R33MH107564
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Social Cognition; Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery

  16 weeks

Study Arms (4)

Oxytocin with SCST

EXPERIMENTAL

Oxytocin with SCST (active condition)

Drug: Oxytocin nasal spray; Behavioral: Social Cognition Skills Training

Oxytocin with Health Management

SHAM COMPARATOR

Administration of OT with control psychosocial treatment

Drug: Oxytocin nasal spray; Behavioral: Health Management

Placebo with SCST

PLACEBO COMPARATOR

Administration of Placebo with active psychosocial treatment

Behavioral: Social Cognition Skills Training; Drug: Placebo nasal spray

Placebo with HM

PLACEBO COMPARATOR

Administration of Placebo with control psychosocial treatment

Behavioral: Health Management; Drug: Placebo nasal spray

Interventions

Oxytocin nasal spray DRUG

nasal spray

Also known as: OT

Oxytocin with Health Management; Oxytocin with SCST

Social Cognition Skills Training BEHAVIORAL

Group based training in social cognition skills

Also known as: SCST

Oxytocin with SCST; Placebo with SCST

Health Management BEHAVIORAL

Group-based training in mental health management

Also known as: HM

Oxytocin with Health Management; Placebo with HM

Placebo nasal spray DRUG

placebo condition

Also known as: PBO

Placebo with HM; Placebo with SCST

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schizophrenia or schizoaffective disorder
• stable on an antipsychotic medication

You may not qualify if:

• positive pregnancy test history of head injury

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Stephen Marder, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blind Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: January 4, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

US (1)