Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations

Summary

Social cognition impairment is critical to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia spectrum, the autism spectrum and the personality disorders, thus representing a dimension consistent with RDoC. As such, this study aims to a) further characterize the unique deficits in social cognition (recognition and interpretation of social cues and representation of thoughts, intentions, and feelings of others) across disorders, including the schizophrenia spectrum (which includes schizophrenia, SCZ, schizoaffective disorder, SAD, bipolar disorder, BD, and schizotypal personality disorder, SPD), the autism spectrum disorders (ASD), and borderline personality disorder (BPD) compared to healthy controls (HC); b) assess the effect of intranasal oxytocin (OXT) as a regulator and novel treatment of social cognition impairment in these disorders; and c) enhance our understanding of the specificity and exact mechanisms of impairment to inform the accurate dosing of OXT required to modulate social cognition in these disorders and identify a model of optimum social cognitive function. Addressing these questions will further catalyze research into a model of optimum social cognitive activity, and accelerate industry development of agents suited to routine clinical administration.

Conditions

• Borderline Personality Disorder
• BPD
• Schizotypal Personality Disorder
• SPD
• Autism Spectrum Disorder
• Schizophrenia
• Schizoaffective Disorder
• Bipolar Disorder

Interventions

DRUG

Syntocinon 24 Intranasal Units (IU)

DRUG

Syntocinon 40 Intranasal Units (IU)

DRUG

Intranasal Placebo

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center

  collaborator FED

• VISN 3 Mental Illness Research, Education and Clinical Center

  collaborator FED

• Maria de las Mercedes Perez Rodriguez

  lead OTHER

Principal Investigators

• Maria de las Mercedes Perez Rodriguez, MD, PhD · Icahn School of Medicine at Mount Sinai; James J. Peters VA Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2020-07-31

Completion

2022-06-14

Countries

• United States

Study Locations