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

NCT02225600 | Suspended DMC

• 1 other identifier: GCO 13-0744
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Borderline Personality Disorder

Keywords

Borderline Personality Disorder; BPD; Intranasal oxytocin

Outcome Measures

Primary Outcomes (1)

• Trust Game Affect Ratings

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

  up to 4 weeks

Study Arms (2)

patients with BPD

OTHER

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

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

healthy patients

ACTIVE COMPARATOR

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

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

Interventions

40 IU Intranasal Oxytocin DRUG

40 IU intranasal oxytocin

Also known as: OT, Syntocin

healthy patients; patients with BPD

Placebo DRUG

Intranasal Placebo

Also known as: Intranasal Placebo

healthy patients; patients with BPD

24 IU intranasal Oxytocin DRUG

Also known as: syntocin, OT

healthy patients; patients with BPD

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BPD subjects meets criteria for DSM-IV Borderline Personality Disorder.
• 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.

You may not qualify if:

• Substance abuse disorder in the prior 6 months
• Significant medical illness
• Pregnancy
• Metallic foreign-bodies that contraindicate MRI

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Harold Koenigsberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: August 26, 2014
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

US (1)