The Effect of Oxytocin Administration on Interpersonal Cooperation in

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02225600
Study type	Interventional
Source	Icahn School of Medicine at Mount Sinai
Contact	Harold Koenigsberg, MD
Phone	212-241-0441
Email	harold.w.koenigsberg@gmail.com
Status	Recruiting
Phase	N/A
Start date	August 26, 2014
Completion date	March 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms