Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06044090
Other study ID # 21-3111
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 12, 2022
Est. completion date December 19, 2023

Study information

Verified date April 2024
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study seeks to conduct translational work that extends rich preclinical findings to the clinical domain to validate whether neuroinflammatory dysregulation is strongly tied to anhedonia. This project addresses critical gaps in the scientific literature by recruiting a chronically stressed sample of individuals-employment seeking individuals who report significant stress-- and will use an experimental therapeutics approach to attenuate neuroinflammation and assess behavioral changes in motivation. One major obstacle in understanding how neuroinflammation influences motivation involves technological challenges such that conventional approaches are invasive, expensive, and/or lacking specificity. Although static levels of neuroinflammation in humans have been measured via cross sectional studies, capturing behavioral shifts following experimental manipulation has not been done. This gap limits the ability to develop a more precise understanding of how neuroinflammation causes motivational deficits in humans. The proposed project will employ a mechanistic clinical trial of the anti-[neuro]inflammatory agent, minocycline, to address these limitations. In animal models, minocycline has attenuated the deleterious effects of neuroinflammation on neurogenesis, long-term potentiation, and neuronal survival. This study will extend research to humans to examine whether links between neuroinflammation and behavioral responses to a reward-related motivation task differ among chronically stressed individuals taking minocycline and the placebo control. The proposed project will provide preliminary evidence for potential neural targets that have relevance for motivational deficits due to neuroinflammation. Once screening is complete, participants will come to UNC to complete quality-of-life surveys, learn about the full study schedule, and receive the first dose of medication. This visit will last about 90 minutes. Participants will be asked to participate in two medication periods, meaning they will take both minocycline (antibiotic medication) for 5-days, and an inactive substance (placebo sugar pill) for 5-days. This will investigate whether there are changes in their responses to negative and positive information. After taking the first medication for five days, participants will come in to complete computer tasks (Probabilistic Reward Task, Negative Emotion Dot Probe, and Threatening Visual Search Task) and some follow-up surveys (Snaith-Hamilton Pleasure Scale and Motivation and Pleasure Scale). This visit will last about 90 minutes. Participants will then get at least a 2-week break before taking the second medication for five days. Then, they will come back for another 90-minute visit to complete the same computer tasks and follow-up surveys. The total study duration including the break is about one month. The total time in study sessions on campus over the month will be 4.5 hours.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 19, 2023
Est. primary completion date December 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: - 25-50 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 Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Howell Hall Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Snaith Hamilton Pleasure Scale score The Snaith-Hamilton Pleasure Scale (SHAPS) is a tool to assess symptoms of reduced motivation. The SHAPS uses 14 questions, each rated on a Likert scale of 1-4. The total score on the scale ranges from 14-56, with lower scores reflecting lower motivation. Scores will be compared across conditions to determine whether motivation changes in the minocycline condition as compared to the placebo. within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo
Secondary Change in Motivation and Pleasure Scale (MAPS) score The Motivation and Pleasure Scale (MAP) will be used to capture self-reported aspects of reduced motivation. The scale uses 18 questions, each rated on a Likert scale of 0-4. The total score on the scale ranges from 0-72, with lower scores reflecting lower motivation. Scores will be compared across conditions to determine whether motivation changes in the minocycline condition as compared to the placebo. within approximately 24 hours after the final dose; Day 6 minocycline to Day 6 placebo
See also
  Status Clinical Trial Phase
Completed NCT04549194 - Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Completed NCT03689348 - Acute and Chronic Effects of Avena Sativa on Cognition and Stress N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05991739 - Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families N/A
Not yet recruiting NCT05491122 - The Influence of Fluid Intake on Daily Biological Rhythm and Mental Performance in Healthy Young Adults N/A
Completed NCT02844478 - Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging N/A
Completed NCT02982070 - TU Tough: Mental Toughness Training for College Success N/A
Completed NCT02417454 - Study on the Effects of a Probiotic on Autonomic and Psychological Stress Phase 3
Completed NCT06014970 - The Health and Wellness Curriculum Assessment N/A
Completed NCT01946893 - Mindfulness Meditation for Cognition and Mood N/A
Completed NCT01637363 - Psychoeducation to Sick-listed Individuals With Mental Health Problems N/A
Completed NCT01343810 - Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers N/A
Completed NCT00661271 - Mindfulness-based Stress Reduction for Urban Youth N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Completed NCT04125810 - A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress Phase 2
Completed NCT04023968 - Student Wellness Workshop Study N/A
Completed NCT03233750 - Simulation-Based Stress Inoculation Training N/A