Current partner codePEPTIDESDE
NCT02225600·Not applicable·INTERVENTIONAL

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

Status

Suspended

Phase

Not applicable

Enrollment

40

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

DRUG

40 IU Intranasal Oxytocin

40 IU intranasal oxytocin

DRUG

Placebo

Intranasal Placebo

DRUG

24 IU intranasal Oxytocin

Timeline

From registration to results.

  1. First posted

    Aug 26, 2014

  2. Study start

    Aug 26, 2014

  3. Primary completion

    Jul 2027

  4. Study completion

    Dec 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 2, 2026

Outcomes

What the study measures.

Primary outcomes

Trust Game Affect Ratings

Time frame · up to 4 weeks

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
55 Years
Sex
ALL
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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Oxytocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.