Role Of Sensitivity to neuroEndocrine Systems in Social Decisions

NCT06018727 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 22-1839
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 answer is how neuroendocrine activity impacts decision-making. This study has two components. First, there will be an online session that participants complete to consent into the study, complete self-report surveys and a cognitive assessment, and confirm their eligibility for the second part of the study. If eligible to continue, participants will complete one in-person experiment session, during which they will complete self-report measures and a decision-making task. During the in-person session, participants will be randomly assigned (like flipping a coin) to ingest either a placebo (non-active) or the combination of hydrocortisone and yohimbine.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (3)

• Goal-directed decision-making in the Social Decision Tree Task (SDTT)

  Measured by choice behavior in SDTT, which is based on the decision tree framework. After each action, participants receive feedback about the effect of that action and the extent to which it added to or took away from their points. If participants make a given choice, the subsequent actions that they can choose are different than if they were to initially make a different choice. An action in SDTT is goal-directed if the possible net gain an individual can earn before the end of the current epoch (a "day" in the SDTT) is equal to or higher than the amount they could gain by choosing the alternative action. The investigators will subset trials so that 1 is coded as choosing the immediately valuable action at the expense of the optimal and 0 is coded as choosing the optimal at the expense of the immediately valuable action. This outcome variable is binary. An action is defined as social if it is paired with a visual cue with a face on it and non-social if not.

  Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study

• Change in salivary cortisol

  The investigators will collect a saliva sample immediately before participants ingest the drugs (or placebos, if in the control condition). They will collect a second saliva sample 45 minutes after the drug (or placebo) ingestion. They will measure cortisol levels in both samples through an assay. The investigators will calculate the change in salivary cortisol by subtracting the measured cortisol in the first saliva sample (collected pre-drug/placebo ingestion) from the measured cortisol in the second saliva sample (collected 45 minutes after the drug/placebo ingestion). Salivary cortisol is measured as nmol/L. Salivary cortisol expected to generally be below 200 nmol/L.

  Collected immediately before the drug/placebo administration (~5 minutes into the session) and 45 minutes after the drug/placebo administration (~50 minutes into the session) in Session 2, which takes place on approximately Day 7

• Pupil diameter during SDTT

  The outcome will be measured using eye tracking technology.

  Collected for 30 minutes ~1 hour into Session 2, which takes place on approximately Day 7 of the study

Secondary Outcomes (3)

• Change in valence, measured via the affect grid

  Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7

• Change in arousal, measured via the affect grid

  Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7

• Change in stress, measured via the subjective stress scale

  Collected immediately before the first saliva collection in Session 2 (~5 minutes into the session) and 45 minutes after the second saliva collection in Session 2 (~50 minutes into the session), which takes place on approximately Day 7

Other Outcomes (15)

• Personality Assessment Inventory-Borderline Scale (PAI-BOR) score

  Session 1, which takes place on Day 0

• Interbeat Interval (IBI) time series during SDTT

  Collected approximately 1 hour into Session 2 for 30 minutes (which takes place on approximately Day 7)

• Heart rate variability (HRV) during SDTT

  Collected approximately 1 hour into Session 2 for 30 minutes (which takes place on approximately Day 7)

Study Arms (2)

Hydrocortisone + Yohimbine

EXPERIMENTAL

Participants will ingest hydrocortisone and yohimbine during Session 2 approximately 10 minutes into the session.

Drug: Hydrocortisone; Dietary Supplement: Yohimbine

Placebo + Placebo

PLACEBO COMPARATOR

Participants will orally ingest two placebos during Session 2 approximately 10 minutes into the session.

Drug: Placebo

Interventions

Hydrocortisone DRUG

Hydrocortisone 20 mg capsule will be administered orally.

Also known as: Cortef

Hydrocortisone + Yohimbine

Yohimbine DIETARY_SUPPLEMENT

Yohimbine 20 mg capsule will be administered orally.

Also known as: Yohimbine Hydrochloride

Hydrocortisone + Yohimbine

Placebo DRUG

Two placebos will be administered orally.

Also known as: Sugar pill

Placebo + Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• + 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
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Huys QJ, Eshel N, O'Nions E, Sheridan L, Dayan P, Roiser JP. Bonsai trees in your head: how the pavlovian system sculpts goal-directed choices by pruning decision trees. PLoS Comput Biol. 2012;8(3):e1002410. doi: 10.1371/journal.pcbi.1002410. Epub 2012 Mar 8.

  PMID: 22412360 BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Hydrocortisone; Yohimbine; Sugars

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Carbohydrates

Study Officials

• Michael N Hallquist, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 31, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 5, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)