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

Primary Purpose

Borderline Personality Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

40 IU Intranasal Oxytocin

Placebo

24 IU intranasal Oxytocin

About this trial

This is an interventional other trial for Borderline Personality Disorder focused on measuring Borderline Personality Disorder, BPD, Intranasal oxytocin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

patients with BPD

healthy patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Trust Game Affect Ratings

Behavioral differences between groups based on Scale with 1= most negative to 5=most positive

Secondary Outcome Measures

Full Information

NCT ID

NCT02225600

First Posted

August 22, 2014

Last Updated

March 14, 2023

Sponsor

Icahn School of Medicine at Mount Sinai

1. Study Identification

Unique Protocol Identification Number

NCT02225600

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 26, 2014 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Borderline Personality Disorder

Keywords

Borderline Personality Disorder, BPD, Intranasal oxytocin

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients with BPD

Arm Type

Other

Arm Description

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

Arm Title

healthy patients

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

40 IU Intranasal Oxytocin

Other Intervention Name(s)

OT, Syntocin

Intervention Description

40 IU intranasal oxytocin

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Intranasal Placebo

Intervention Description

Intranasal Placebo

Intervention Type

Drug

Intervention Name(s)

24 IU intranasal Oxytocin

Other Intervention Name(s)

syntocin, OT

Primary Outcome Measure Information:

Title

Trust Game Affect Ratings

Description

Behavioral differences between groups based on Scale with 1= most negative to 5=most positive

Time Frame

up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Harold Koenigsberg, MD

Phone

212-241-0441

harold.w.koenigsberg@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harold Koenigsberg, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harold Koenigsberg, MD

harold.w.koenigsberg@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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