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

NCT ID: NCT02225600

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-26
• Study Completion Date: 2027-12-31

Brief 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.

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

patients with BPD

cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo

Group Type: OTHER

40 IU Intranasal Oxytocin

Intervention Type: DRUG

40 IU intranasal oxytocin

Placebo

Intervention Type: DRUG

Intranasal Placebo

24 IU intranasal Oxytocin

Intervention Type: DRUG

healthy patients

Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo

Group Type: ACTIVE_COMPARATOR

40 IU Intranasal Oxytocin

Intervention Type: DRUG

40 IU intranasal oxytocin

Placebo

Intervention Type: DRUG

Intranasal Placebo

24 IU intranasal Oxytocin

Intervention Type: DRUG

Interventions

40 IU Intranasal Oxytocin

40 IU intranasal oxytocin

Intervention Type: DRUG

Placebo

Intranasal Placebo

Intervention Type: DRUG

24 IU intranasal Oxytocin

Intervention Type: DRUG

Other Intervention Names

OT; Syntocin; Intranasal Placebo; syntocin; OT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Harold W Koenigsberg, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harold Koenigsberg, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 13-0744

Identifier Type: -

Identifier Source: org_study_id