Status:
WITHDRAWN
Role Of Sensitivity to neuroEndocrine Systems in Social Decisions
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Borderline Personality Disorder
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to investigate how personality traits and neuroendocrine systems relate to decision-making patterns in individuals 18-45 years old. The main question it aims to a...
Detailed Description
This study has two components. First, there will be a 60 minute online session. During this session, participants will first be asked to complete the informed consent process, a demographics and conta...
Eligibility Criteria
Inclusion
- Borderline Personality Disorder (BPD) group:
- Score of 38 or higher on PAI-BOR
- Participants in the BPD group will be primarily recruited from the two DEPENd lab studies that maintain large samples of BPD participants. To ensure maximal similarity between BPD participants recruited from other DEPENd lab studies and BPD participants recruited through other recruitment sources, the investigators will use the same criteria for the BPD group in the ROSES study as the criteria used in the other DEPENd lab studies. BPD participants in the two DEPENd lab studies from which the investigators will be recruiting must meet the following criteria:
- 3+ BPD symptoms, one of which must be affective instability, per clinical interview
- Participants must score at least 80 on the Reynolds Intellectual Screening Test (RIST).
- Matched Control (MC) group:
- Score of 12 or lower on PAI-BOR
- Score below 50th percentile on WHODAS
- Combined
- Ages 18-45
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
- Willingness to participate in all components of the study
- Access to necessary resources for participating in the virtual Session 1 (i.e., computer, smartphone, internet access)
- Participants must be able to speak, understand and read English.
- Participants must have at least 20/40 visual acuity (correct or uncorrected).
Exclusion
- Current use of medications that interact adversely with yohimbine
- a. Iobenguane radiopharmaceutical products
- Current use of medications that interact adversely with hydrocortisone
- Aldesleukin
- Bacillus Calmette-Guérin (BCG) Products
- Cladribine
- Dengue Tetravalent Vaccine
- Desmopressin
- Indium 111 Capromab Pendetide
- Macimorelin
- Mifamurtide
- MiFEPRIStone
- Natalizumab
- Pimecrolimus:
- Ruxolitinib (Topical)
- Tacrolimus (Topical)
- Talimogene Laherparepvec
- Tertomotide
- Phenytoin
- Rifampin
- Troleandomycin
- Ketoconazole
- High-dose aspirin (\>30 mg/kg/day)
- Contraindicated medical conditions of yohimbine
- Renal dysfunction
- Hepatic dysfunction
- Heart failure
- Psychotic Disorder or psychosis
- Hypotension
- Diabetes
- Heart disease
- Kidney disease
- Liver disease
- Nervous disorder
- Gastric ulcer
- Duodenal ulcer
- Contraindicated medical conditions of hydrocortisone
- Hypersensitivity to hydrocortisone or any component of the formulation
- Systemic fungal infections
- Latent Tuberculosis, Tuberculosis reactivity, active Tuberculosis
- Cardiovascular disease
- Diabetes
- Gastrointestinal diseases
- i. Diverticulitis ii. Fresh intestinal anastomoses iii. Active or latent peptic ulcer iv. Ulcerative colitis v. Abscess vi. Renal insufficiency vii. Other pyogenic infection g. Hepatic impairment h. Kidney impairment i. Myasthenia gravis j. Osteoporosis k. Pheochromocytoma l. Seizure disorders m. Septic shock or sepsis syndrome n. Systemic sclerosis o. Thyroid disease p. Strongyloides (threadworm) infestation q. Ocular herpes simplex r. Hypertension
- Given a live vaccine within 2 weeks of completing Visit 1. Recent administration of the following vaccines are specifically contraindicated for hydrocortisone:
- Typhoid Vaccine
- Yellow Fever Vaccine
- Poliovirus Vaccine (Live/Trivalent/Oral)
- Rubella- or Varicella-Containing Live Vaccines
- Have a current infection
- Pregnancy
- Individuals lactating
- Recent antihypertensive agents
- History of psychotic disorder, Bipolar I disorder, autism spectrum disorder, reactive attachment disorder, pervasive developmental disorder, motor disorder, head injury, mental retardation, neurological disorder, or current substance dependence
- Family history of Bipolar I disorder in a first degree relative.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06018727
Start Date
July 1 2024
End Date
July 1 2025
Last Update
June 5 2024
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514