Brain and Stress Study

NCT06044090 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 21-3111
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Motivational deficits such as anhedonia are core to several psychiatric disorders and underlie significant functional impairment. This double-blind, placebo-controlled crossover trial of minocycline, an anti-\[neuro\]inflammatory agent, examines links between chronic stress and responses to a reward-related motivation task. It will evaluate the effects of pharmacologically attenuating neuroinflammation on behavioral responses to a reward-related motivation task in individuals experiencing unemployment. Understanding the effects of neuroinflammation on reward function among individuals experiencing chronic stress represents a critical first step in identifying novel neuroimmune targets for future clinical trials.

Conditions

Stress, Psychological; Motivation

Outcome Measures

Primary Outcomes (1)

• Change in Response Bias During the Probabilistic Reward Task

  The aim of Probabilistic Reward Task (PRT) is to win as much money as possible by correctly identifying the presence of a short versus long mouth on a cartoon face. The task aims to produce a response bias toward the mouth length that is more often positively reinforced. The response bias score is a ratio of the number of times the participant chooses the high reward versus the low reward stimulus. Scores range from -1 to +1, with a positive score indicating a stronger bias toward the high reward stimulus. The change in response bias is calculated by subtracting response bias during the PRT in the placebo condition from the minocycline condition. This difference measures an individual's change in reward behavior after a 5-day dosage of an anti-neuroinflammatory agent.

  within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

Secondary Outcomes (2)

• Change in Snaith Hamilton Pleasure Scale Score

  within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

• Change in Motivation and Pleasure Scale (MAPS) Score

  within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo

Study Arms (2)

Placebo followed by Minocycline

EXPERIMENTAL

In this arm, participants will take a 5-day course of placebo-control pills and then a 5-day course of 200 mg of minocycline. Sessions will be separated by a minimum washout period of 14 days.

Drug: Minocycline; Drug: Placebo

Minocycline followed by Placebo

EXPERIMENTAL

In this arm, participants will take a 5-day course of 200 mg of minocycline and then a 5-day course of placebo-control pills. Sessions will be separated by a minimum washout period of 14 days.

Drug: Minocycline; Drug: Placebo

Interventions

Minocycline DRUG

Participants will take 2 pills of 100 mg totaling a 200 mg dose of minocycline per day.

Also known as: Minocin, Solodyn, Ximino, CoreMino

Minocycline followed by Placebo; Placebo followed by Minocycline

Placebo DRUG

A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 2 placebo tablets matching the Minocycline tablets daily for 5 days.

Also known as: sugar pill

Minocycline followed by Placebo; Placebo followed by Minocycline

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Unemployed (working less than 20 hours per week)
• Have been unemployed for at least 6 months
• Seeking employment
• Having trouble finding a job (i.e., actively seeking and applying for jobs but not successful in landing a job)
• Reports greater than 5 points on Job Stress Items
• Regular access to a mobile phone

You may not qualify if:

• Self-reported physical illnesses: diabetes, cardiovascular diseases, high blood pressure, inflammatory bowel diseases, rheumatoid arthritis, asthma, autoimmune disease, Crohn's disease, ulcerative colitis, lupus
• neurological conditions (e.g., Traumatic Brain Injury, stroke)
• pregnant (as measured by urine pregnancy screen) or breastfeeding
• current use of psychotropic medications
• Current regular recreational drug or alcohol use (i.e., 4 or more times per week)
• chronic diseases that significantly impact inflammatory markers (e.g., cancer)
• known allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs
• current antibiotic use
• regular use of steroidal or non-steroidal anti-inflammatory medications (i.e., 2 or more times a week)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Howell Hall

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (3)

• Kangas BD, Der-Avakian A, Pizzagalli DA. Probabilistic Reinforcement Learning and Anhedonia. Curr Top Behav Neurosci. 2022;58:355-377. doi: 10.1007/7854_2022_349.

  PMID: 35435644 BACKGROUND

• Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.

  PMID: 7551619 BACKGROUND

• Llerena K, Park SG, McCarthy JM, Couture SM, Bennett ME, Blanchard JJ. The Motivation and Pleasure Scale-Self-Report (MAP-SR): reliability and validity of a self-report measure of negative symptoms. Compr Psychiatry. 2013 Jul;54(5):568-74. doi: 10.1016/j.comppsych.2012.12.001. Epub 2013 Jan 22.

  PMID: 23351831 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Minocycline; Sugars

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Gabriella Alvarez, PhD
• Organization: University of Pittsburgh

gabyalvarez@pitt.edu

412-624-4500

Study Officials

• Gabriella Alvarez, PhD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

• Keely Muscatell, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 12, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)