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SuspendedNCT02225600Updated Jul 2, 2026

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

An interventional study of 40 IU Intranasal Oxytocin and Placebo in Borderline Personality Disorder, sponsored by Icahn School of Medicine at Mount Sinai. Suspended at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Other

Why this study was suspended
Study was halted during COVID pandemic. However, PI is currently reconnecting with a compounding pharmacy to re-establish supply of the oxytocin and updating cost estimates. We are hoping to resume the pilot work with oxytocin once it is clarified.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Borderline Personality Disorder

Keywords

  • Borderline Personality Disorder
  • BPD
  • Intranasal oxytocin
03

In context

Borderline Personality Disorder

269 studies on the registry are indexed under Borderline Personality Disorder; 67 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 215 interventional studies indexed under Borderline Personality Disorder.

Browse Borderline Personality Disorder studies →

Lead sponsor

Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.

Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Other
    patients with BPD

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

    Drug: 40 IU Intranasal Oxytocin · Drug: Placebo · Drug: 24 IU intranasal Oxytocin

  • Active comparator
    healthy patients

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

    Drug: 40 IU Intranasal Oxytocin · Drug: Placebo · Drug: 24 IU intranasal Oxytocin

Interventions

  • Drug40 IU Intranasal Oxytocin

    40 IU intranasal oxytocin

    Also known as: OT, Syntocin

  • DrugPlacebo

    Intranasal Placebo

    Also known as: Intranasal Placebo

  • Drug24 IU intranasal Oxytocin

    Also known as: syntocin, OT

06

What researchers measure

Primary outcomes

  1. Trust Game Affect Ratings

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

    Time frame: up to 4 weeks

07

Study locations

1 site
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02225600
Lead sponsor
Icahn School of Medicine at Mount Sinai
Responsible party
Harold W Koenigsberg, MD (Professor, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Aug 26, 2014
Start date
Aug 26, 2014
Primary completion
Jul 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 2, 2026

Study contacts

Harold Koenigsberg, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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