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Trial record 2 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Borderline Personality Disorder"

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

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ClinicalTrials.gov Identifier: NCT02225600
Recruitment Status : Recruiting
First Posted : August 26, 2014
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Harold W Koenigsberg, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: 40 IU Intranasal Oxytocin Drug: Placebo Drug: 24 IU intranasal Oxytocin Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study
Study Start Date : May 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
patients with BPD
cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo
Drug: 40 IU Intranasal Oxytocin
40 IU intranasal oxytocin
Other Names:
  • OT
  • Syntocin

Drug: Placebo
Intranasal Placebo
Other Name: Intranasal Placebo

Drug: 24 IU intranasal Oxytocin
Other Names:
  • syntocin
  • OT

Active Comparator: healthy patients
Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo
Drug: 40 IU Intranasal Oxytocin
40 IU intranasal oxytocin
Other Names:
  • OT
  • Syntocin

Drug: Placebo
Intranasal Placebo
Other Name: Intranasal Placebo

Drug: 24 IU intranasal Oxytocin
Other Names:
  • syntocin
  • OT




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225600


Contacts
Contact: Harold Koenigsberg, MD 212-241-0441 harold.w.koenigsberg@gmail.com

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Harold Koenigsberg, MD       harold.w.koenigsberg@gmail.com   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Principal Investigator: Harold Koenigsberg, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Harold W Koenigsberg, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02225600     History of Changes
Other Study ID Numbers: GCO 13-0744
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by Harold W Koenigsberg, Icahn School of Medicine at Mount Sinai:
Borderline Personality Disorder
BPD
Intranasal oxytocin

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs