Clinical trial NCT02225600: 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
Overall status: SUSPENDED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: Borderline Personality Disorder
BPD
Intranasal oxytocin
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Trust Game Affect Ratings
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Harold Koenigsberg, MD
role: PRINCIPAL_INVESTIGATOR
References: