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

Description

Social cognition impairment is critical to the pathology and morbidity of a number of psychiatric disorders, including the schizophrenia 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) in borderline personality disorder (BPD) and schizotypal personality disorder (SPD) 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.

Study Start Date

September 2013

Estimated Completion Date

June 2016

Interventions

  • Drug: Syntocinon 40 Intranasal Units (IU)
  • Drug: Syntocinon 24 Intranasal Units (IU)
  • Drug: Intranasal Placebo

Specialties

  • Internal Medicine: Clinical Pharmacology,Psychiatry
  • Psychiatry: Anxiety,Personality Disorders,Schizophrenia/Psychosis
  • Family Medicine: Psychiatry
  • Pharmacy: Dosing,Neuro/Psych pharmacology

MeSH Terms

  • Borderline Personality Disorder
  • Personality Disorders
  • Schizotypal Personality Disorder
  • Syntocinon

Study ID

Mount Sinai School of Medicine -- GCO 13-0340

Status

Unknown

Trial ID

NCT02149823

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

45

Sponsor

Mount Sinai School of Medicine

Inclusion Criteria

  • 18 ? age ? 60
  • Medically and neurologically healthy
  • Willing and able to provide informed consent
  • IQ?80

Exclusion Criteria

  • Currently meets or has met criteria for autism, bipolar I, schizophrenia or other psychotic disorder
  • 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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
James J Peters VA Medical Center - Bronx, New York 41.7 miles Harold Koenigsberg MD 212-427-6600 harold.koenigsberg@mssm.edu
Icahn School of Medicine at Mount Sinai - New York, New York 46.8 miles Maria de las Mercedes Perez Rodriguez MD PhD 212-241-4774 Mercedes.Perez@Mssm.edu

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