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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT02225600

Collaborator

(none)

Enrollment

Location

Arms

130

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Borderline Personality Disorder	Drug: 40 IU Intranasal Oxytocin Drug: Placebo Drug: 24 IU intranasal Oxytocin	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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: syntocin OT
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: syntocin OT

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:

Syntocin

Drug: Placebo

Intranasal Placebo

Other Names:

Intranasal Placebo

Drug: 24 IU intranasal Oxytocin

Other Names:

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:

Syntocin

Drug: Placebo

Intranasal Placebo

Other Names:

Intranasal Placebo

Drug: 24 IU intranasal Oxytocin

Other Names:

syntocin

Outcome Measures

Primary Outcome Measures

Trust Game Affect Ratings [up to 4 weeks]
Behavioral differences between groups based on Scale with 1= most negative to 5=most positive

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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