DRUG
40 IU Intranasal Oxytocin
40 IU intranasal oxytocin
Status
Suspended
Phase
Not applicable
Enrollment
40
Locations
1
Results
Not posted
Publications
0
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.
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
DRUG
40 IU intranasal oxytocin
DRUG
Intranasal Placebo
DRUG
Timeline
First posted
Aug 26, 2014
Study start
Aug 26, 2014
Primary completion
Jul 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jul 2, 2026
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
Not reported in the indexed record.
Eligibility
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
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
No PMID-linked publications were present in this registry snapshot.
Related trials
Wake Forest University Health Sciences · Total Hip Arthroplasty
Phase 2
Enrolling by invitation
80
2026-07
Yale University · Pain · Pituitary Surgery
Phase 2
Not yet recruiting
75
2026-07
Medical University of South Carolina · PTSD · Alcohol Use Disorder
Phase 2
Completed
175
2026-07
University Hospital, Tours · Cervical Ripening · Unfavorable Cervix
Phase 3
Recruiting
1,494
2026-07
Icahn School of Medicine at Mount Sinai · Pregnancy · Labor
Phase 3
Recruiting
281
2026-07
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Aalto University · Induction of Birth · Cervical Ripening
Not applicable
Recruiting
40
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.