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

• Status: Suspended
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Maria de las Mercedes Perez Rodriguez
• Collaborators: James J. Peters Veterans Affairs Medical Center; VISN 3 Mental Illness Research, Education and Clinical Center
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• 18 ≤ age ≤ 65

• Medically and neurologically healthy

• Willing and able to provide informed consent

• IQ≥80

Exclusion Criteria:

• Currently meets for a psychotic episode

• Clinically significant cardiovascular or neurological conditions, traumatic brain injury, uncontrolled hypertension, clinically significant EKG abnormalities, or serious general medical illness

• Clinical evidence of dehydration or significant hypotension; pregnant or lactating

• Currently meets DSM-IV-TR criteria for MDD

• Current substance abuse (last 6 months) or past dependence on stimulants, opioids or other potentially neurotoxic drugs

• Currently taking psychotropic or other systemic medications

• Non-English speaking