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Hormone Therapy
Intranasal Oxytocin for Borderline Personality Disorder
N/A
Recruiting
Led By Harold Koenigsberg, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 55 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights
Study Summary
This trial will study how people with borderline personality disorder behave differently than healthy people when playing a trust game, and whether a hormone called oxytocin can help normalize their behavior.
Who is the study for?
This trial is for adults aged 18-55 with Borderline Personality Disorder (BPD) or healthy individuals without major psychiatric conditions. Participants should not be on psychotropic medications for at least 2 weeks and can be in psychotherapy. BPD patients must meet DSM-IV criteria, excluding certain other mental health disorders, substance dependence, and severe medical issues.Check my eligibility
What is being tested?
The study tests if intranasal Oxytocin (OT), given at doses of either 24 IU or 40 IU, affects trust behaviors differently in BPD patients compared to healthy adults during a trust game. It also looks at how OT might change brain activity related to these behaviors.See study design
What are the potential side effects?
Possible side effects from intranasal Oxytocin may include irritation inside the nose, headache, nausea, changes in heart rate or blood pressure, and emotional changes like increased anxiety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Trust Game Affect Ratings
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: patients with BPDExperimental Treatment3 Interventions
cross-over administration of 40 IU oxytocin, 24 IU oxytocin and placebo
Group II: healthy patientsActive Control3 Interventions
Cross-over of 40 IU oxytocin, 24 IU oxytocin and placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
868 Previous Clinical Trials
527,087 Total Patients Enrolled
3 Trials studying Borderline Personality Disorder
247 Patients Enrolled for Borderline Personality Disorder
Harold Koenigsberg, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
78 Total Patients Enrolled
1 Trials studying Borderline Personality Disorder
78 Patients Enrolled for Borderline Personality Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently participating in psychotherapy.Healthy controls are people who do not have a lifetime diagnosis of any mental illness as classified by the DSM-IVI am between 18 and 55 years old.I haven't taken any psychotropic medications for the last 2 weeks, or 6 weeks for fluoxetine.I haven't taken any psychotropic medications for the last 2 weeks, or 6 weeks for fluoxetine.I have BPD without major psychiatric or neurological conditions.I am between 18 and 55 years old.I have been diagnosed with Borderline Personality Disorder.
Research Study Groups:
This trial has the following groups:- Group 1: patients with BPD
- Group 2: healthy patients
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Borderline Personality Disorder Patient Testimony for trial: Trial Name: NCT02225600 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies to join this medical research program?
"Patients with borderline personality disorder aged between 18 and 55 may be eligible to join this clinical trial, in which up to 40 individuals can partake."
Answered by AI
How many individuals are currently partaking in this investigation?
"Yes, the digital records on clinicaltrials.gov confirm that this medical trial is currently accepting applications from prospective participants. It was initially posted on May 1st 2013 and last updated on January 6th 2022, recruiting a total of 40 participants across one location."
Answered by AI
Is this research endeavor admitting individuals above the age of 40?
"According to the requirements, only individuals aged between 18 and 55 are eligible for this trial."
Answered by AI
Is this research program open to enrollment at the present?
"According to the information posted on clinicaltrials.gov, this trial is in its active recruitment phase and has been open since May 1st 2013 with an update released as recently as January 6th 2022."
Answered by AI
What conditions are healthy patients typically prescribed treatments for?
"Healthy patients can be administered oxytocin for the purpose of controlling hemorrhage. This medication is also effective at inducing labor, augmenting uterine contractions and helping to fortify laboring mothers."
Answered by AI
Who else is applying?
What state do they live in?
California
New Jersey
New York
Other
How old are they?
18 - 65
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
What questions have other patients asked about this trial?
How long are screenings typically and is there compensation?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I've tried a variety of medication and have been seeing my current therapist for 2.5 years now. I'm extremely driven to do the work to be able to cope better and it has been frustrating not seeing the progress that I'd like to see.
PatientReceived 1 prior treatment
I had given up a long time trying to find a cure for this **** that has been my life. Resigned myself to my miserable existence and hide away locked up in my house, until my adult child came to me that she has been diagnosed with BPD. I would donate my brain if taking it out and finding the bad parts and how to fix it could happen. I have yet to find a school or doctor that does that, especially when the patient is alive and running her mouth.
I believe its to late for me but I will do anything to help the lost girls like my Beth.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Icahn School of Medicine at Mount Sinai: < 24 hours
Average response time
- < 1 Day
Typically responds via
Phone Call
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