Frontlight ResearchEarly access
SuspendedNo phase
The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults
Key facts
- Who runs it
- Icahn School of Medicine at Mount Sinai
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Suspended
- People taking part
- 40 people, planned
- Started
- 26 Aug 2014
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- 40 IU Intranasal Oxytocin
- Placebo
- 24 IU intranasal Oxytocin
- Record updated
- 2 July 2026
- Why it stopped
- 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.
Who can take part
- Age
- 18 years to 55 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Substance abuse disorder in the prior 6 months
- 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
- Significant medical illness
- Pregnancy
- Metallic foreign-bodies that contraindicate MRI
Where in United States
- Icahn School of Medicine at Mount SinaiNew York, United States
About the trial
What the trial wants to find out
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 2 groups in the trial
- patients with BPDOther group
cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo
Treatment: 40 IU Intranasal Oxytocin, Placebo, and 24 IU intranasal Oxytocin
- healthy patientsExisting treatment, for comparison
Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo
Treatment: 40 IU Intranasal Oxytocin, Placebo, and 24 IU intranasal Oxytocin
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study
- Record updated
- 2 July 2026