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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.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with BPD | Other | cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo |
|
| healthy patients | Active Comparator | Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40 IU Intranasal Oxytocin | Drug | 40 IU intranasal oxytocin |
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| Measure | Description | Time Frame |
|---|---|---|
| Trust Game Affect Ratings | Behavioral differences between groups based on Scale with 1= most negative to 5=most positive | up to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold Koenigsberg, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| Placebo | Drug | Intranasal Placebo |
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| 24 IU intranasal Oxytocin | Drug |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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