Borderline Personality DisorderNCT02225600
The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults
A study testing 40 IU Intranasal Oxytocin and 24 IU intranasal Oxytocin in people with Borderline Personality Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- 40 IU Intranasal Oxytocin and 24 IU intranasal Oxytocin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2014to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study
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.
Read the 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.
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.
- Conditions
- Borderline Personality Disorder
- Being tested
- 40 IU Intranasal Oxytocin, Placebo, 24 IU intranasal Oxytocin
- Keywords
- Borderline Personality Disorder, BPD, Intranasal oxytocin
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40 IU Intranasal OxytocinDrug
Also called OT, Syntocin
40 IU intranasal oxytocin
PlaceboDrug
Also called Intranasal Placebo
Intranasal Placebo
24 IU intranasal OxytocinDrug
Also called syntocin, OT
| Study group | Role | What they receive |
|---|---|---|
| patients with BPD | Other | cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo Receives: 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 Receives: Drug: 40 IU Intranasal Oxytocin; Drug: Placebo; Drug: 24 IU intranasal Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trust Game Affect Ratings
Behavioral differences between groups based on Scale with 1= most negative to 5=most positive
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study start26 Aug 2014
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harold W Koenigsberg, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Harold Koenigsberg, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225600
- Sponsor's protocol ID
- GCO 13-0744
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2014
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults: A Pilot Behavioral Study
- ClinicalTrials.gov ID
- NCT02225600
- Acronym / sponsor ID
- GCO 13-0744
- Conditions
- Borderline Personality Disorder
- Keywords
- Borderline Personality Disorder, BPD, Intranasal oxytocin
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 26 Aug 2014 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with BPD | Other | Drug: 40 IU Intranasal Oxytocin, Drug: Placebo, Drug: 24 IU intranasal Oxytocincross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo |
| healthy patients | Active comparator | Drug: 40 IU Intranasal Oxytocin, Drug: Placebo, Drug: 24 IU intranasal OxytocinCross-over of 40 IU oxytocin, 24 IU oxytocin and placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40 IU Intranasal OxytocinAlso: OT, Syntocin40 IU intranasal oxytocin | Drug | healthy patients, patients with BPD |
| PlaceboAlso: Intranasal PlaceboIntranasal Placebo | Drug | healthy patients, patients with BPD |
| 24 IU intranasal OxytocinAlso: syntocin, OT | Drug | healthy patients, patients with BPD |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harold Koenigsberg, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 40 IU Intranasal Oxytocin and 24 IU intranasal Oxytocin in people with Borderline Personality Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trust Game Affect Ratings (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.