The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults

The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study

The study will examine behavioral patterns and underlying neural correlates which distinguish patients with borderline personality disorder (BPD) from healthy subjects as they participate in a two-person trust game and will determine whether administration of intranasal oxytocin (OT) will normalize trust game performance and concomitant neural processing in the BPD group.

Study Overview

• Status: Suspended
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Drug: 40 IU Intranasal Oxytocin; Drug: Placebo; Drug: 24 IU intranasal Oxytocin

Detailed Description

This is a pilot study to support submission of a larger-scale federally funded study. The study is designed to develop new strategies for treating the severe interpersonal dysfunction in borderline personality disorder (BPD) by modeling the interpersonal disturbance in BPD in the laboratory, identifying its neural correlates and determining whether the social neuropeptide, oxytocin, can ameliorate the interpersonal dysfunction. The study will examine behavioral patterns and underlying neural correlates which distinguish patients with borderline personality disorder (BPD) from healthy subjects as they participate in a two-person trust game and will determine whether administration of intranasal oxytocin (OT) will normalize trust game performance and concomitant neural processing in the BPD group.

The specific aims of the study are: 1) to determine whether BPD patients and healthy controls (HC) differ in their pattern of investing in a trustee when the trustee behaves benevolently or malevolently towards them or suddenly becomes malevolent after a period of benevolence (or vice-versa) in a multi-round economic exchange game ("The Trust Game"), and 2) to determine the effect upon behavior of the administration of 40 IU intranasal oxytocin relative to placebo in BPD subjects and HC's engaged in the Trust Game.

Subjects are being recruited and may participate in the Trust Game task, but intranasal administration of oxytocin has temporarily been held because of the COVID-19 pandemic.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BPD subjects meets criteria for DSM-IV Borderline Personality Disorder.
• 18 to 55 years old
• Healthy controls are free of any lifetime DSM-IV Axis I or Axis II diagnosis. However, to avoid a group of HC's too highly groomed and unrepresentative of the general population subjects meeting criteria for a past Axis I diagnosis of adjustment, dysthymic, or depressive NOS disorders, specific phobias, and sleep disorders will not be excluded. Subjects will not be excluded for a non-IV substance abuse disorder more than 6 months prior to enrollment.
• All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine).
• Subjects may be enrolled in psychotherapy.

Exclusion Criteria:

• BPD subjects not meeting DSM-IV criteria for past or present bipolar I disorder, schizophrenia, schizoaffective disorder, substance dependence, head trauma, CNS neurological disease, seizure disorder or current major depression. Since depression is commonly associated with BPD, too stringent a depression exclusion criterion would yield a clinically atypical BPD sample. For this reason, BPD patients with Axis I depressive disorders other than major depression and those with a past history of major depression will not be excluded.
• Substance abuse disorder in the prior 6 months
• Significant medical illness
• Pregnancy
• Metallic foreign-bodies that contraindicate MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patients with BPD; cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo	Drug: 40 IU Intranasal Oxytocin; 40 IU intranasal oxytocin; Other Names: OT; Syntocin; Drug: Placebo; Intranasal Placebo; Other Names: Intranasal Placebo; Drug: 24 IU intranasal Oxytocin; Other Names: OT; syntocin
Active Comparator: healthy patients; Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo	Drug: 40 IU Intranasal Oxytocin; 40 IU intranasal oxytocin; Other Names: OT; Syntocin; Drug: Placebo; Intranasal Placebo; Other Names: Intranasal Placebo; Drug: 24 IU intranasal Oxytocin; Other Names: OT; syntocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trust Game Affect Ratings	Behavioral differences between groups based on Scale with 1= most negative to 5=most positive	up to 4 weeks

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Harold Koenigsberg, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2014
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (Estimated): August 26, 2014

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Borderline Personality Disorder; BPD; Intranasal oxytocin
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: GCO 13-0744