Phase 4
N=10
Brain and Stress Study
Stress, Psychological · Motivation
Bottom Line
View on ClinicalTrials.gov: NCT06044090 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Response Bias During the Probabilistic Reward Task — 0.195; 0.203 Ratio (Response Bias Score) — p=0.856
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Minocycline (Drug); Placebo (Drug)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Response Bias During the Probabilistic Reward Task |
0.195; 0.203 | 0.856 |
| SECONDARY Change in Snaith Hamilton Pleasure Scale Score |
3.286; 2.933 | 1.000 |
| SECONDARY Change in Motivation and Pleasure Scale (MAPS) Score |
37.786; 39.267 | 0.225 |
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.
Eligibility Criteria
Inclusion Criteria
- 25-60 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)
Data sourced from ClinicalTrials.gov (NCT06044090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.