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Neuroendocrine Sensitivity for Personality Disorders (ROSES Trial)

Phase 4
Waitlist Available
Led By Michael N Hallquist, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).
3+ BPD symptoms, one of which must be affective instability, per clinical interview
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected for 30 minutes ~1 hour into session 2, which takes place on approximately day 7 of the study
Awards & highlights

ROSES Trial Summary

This trial examines how personality traits & neuroendocrine activity affect decision-making in 18-45 year olds. Participants complete online & in-person tests & are randomly assigned a placebo or hydrocortisone & yohimbine.

Who is the study for?
This trial is for individuals aged 18-45 with Borderline Personality Disorder (BPD) or those who exhibit at least three BPD symptoms, one being affective instability. Participants must speak English, have a certain level of cognitive function and visual acuity. Excluded are those with serious physical illnesses, certain mental health conditions, pregnancy, lactation, recent vaccine administration or medication interactions.Check my eligibility
What is being tested?
The study examines the influence of neuroendocrine activity on decision-making in people with personality traits related to BPD. It involves an online session followed by an in-person experiment where participants ingest either a placebo or hydrocortisone and yohimbine combination to assess their decision-making behavior.See study design
What are the potential side effects?
Potential side effects from hydrocortisone may include mood swings, increased blood sugar levels, and risk of infection. Yohimbine can cause rapid heart rate, high blood pressure and anxiety. The placebo should not have active side effects but can result in a psychological response.

ROSES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My score on the RIST is 80 or higher.
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I have been diagnosed with 3 or more symptoms of BPD, including mood swings.
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I am between 18 and 45 years old.

ROSES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected approximately 1 hour into session 2 for 30 minutes (which takes place on approximately day 7)
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected approximately 1 hour into session 2 for 30 minutes (which takes place on approximately day 7) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in salivary cortisol
Goal-directed decision-making in the Social Decision Tree Task (SDTT)
Pupil diameter during SDTT
Secondary outcome measures
Change in arousal, measured via the affect grid
Change in stress, measured via the subjective stress scale
Change in valence, measured via the affect grid
Other outcome measures
Alcohol Use Disorders Identification Test (AUDIT) Score
Big Five Inventory (BFI-II) Score
Drug Use Disorders Identification Test (DUDIT) Score
+12 more

ROSES Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hydrocortisone + YohimbineExperimental Treatment2 Interventions
Participants will ingest hydrocortisone and yohimbine during Session 2 approximately 10 minutes into the session.
Group II: Placebo + PlaceboPlacebo Group1 Intervention
Participants will orally ingest two placebos during Session 2 approximately 10 minutes into the session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yohimbine
2002
Completed Phase 4
~790
Hydrocortisone
2005
Completed Phase 4
~1260

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,721 Total Patients Enrolled
Michael N Hallquist, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Hydrocortisone + Yohimbine for medicinal purposes?

"The combination of hydrocortisone and yohimbine achieved a score of 3 on our risk assessment scale, as this is an approved treatment at the Phase 4 stage."

Answered by AI

Does this experiment involve any participants of legal age?

"This research is recruiting participants aged 18-45."

Answered by AI

Am I eligible to take part in this clinical trial?

"This clinical trial seeks 104 participants aged between 18 and 45 who are presently diagnosed with Borderline personality disorder (BPD). In order to be eligible, patients must demonstrate a score of 38 or higher on the PAI-BOR scale, display at least three BPD symptoms (one being affective instability as verified by an interview), have a WHODAS Score below 50th percentile, and register 12 or lower on the PAI-BOR."

Answered by AI

Can individuals still join this clinical experiment?

"Per the details available on clinicaltrials.gov, this research is not currently taking in participants - though it was first posted on October 1st 2023 and last modified a month prior to that date. Despite this trial's paused recruitment process, there are presently 63 other studies actively searching for study subjects."

Answered by AI

Who else is applying?

What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Role Of Sensitivity to neuroEndocrine Systems in Social Decisions
2024. "Role Of Sensitivity to neuroEndocrine Systems in Social Decisions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06018727.
All > Borderline Personality Disorder
~69 spots leftby Jul 2025
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