RecruitingPhase 4

Anti-Inflammatory Challenge in Schizophrenia

United States60 participantsStarted 2024-04-18

Plain-language summary

This study aims to illuminate the biological underpinnings of negative symptoms in schizophrenia-particularly motivational impairments-by probing the link between systemic inflammation and neural activity in reward-related brain circuits. The primary goal of this study is to determine: * Ventral Striatum Activation: Assess how reward anticipation engages the ventral striatum in individuals with schizophrenia, both before and after an anti-inflammatory intervention. * Anterior Insula Activation: Examine how increasing effort demands modulate activity in the anterior insula under the same conditions.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men or women, 18-55 years of age with a primary diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) schizophrenia or schizoaffective disorder; * Willing and able to give written informed consent; * Plasma CRP ≥2 mg/L; * Significant motivational deficit as reflected by a score \>17 on the Motivation and Pleasure Domain of the Brief Negative Symptom Scale. Of note, for patients who exhibit CRP\>10mg/L, additional CRP testing will be conducted at 2-week intervals as per American Heart Association/ Center for Disease and Control Prevention guidelines to establish stability and rule out acute inflammation/infection (along with physical exam and laboratory testing). * Patients must also have a negative urine drug screen at all study visits. Exclusion Criteria: * Any autoimmune disorder (as confirmed by laboratory testing); * History of tuberculosis infection as determined by QuantiFERON Gold or high risk of tuberculosis exposure; * Active hepatitis B or C infection or human immunodeficiency virus infection (as established by laboratory testing); * History of any type of cancer; * History of fungal infection; * History of recurrent viral or bacterial infections; * Unstable cardiovascular (including evidence of congestive heart failure as determined by physical examination and laboratory testing), endocrinologic, hematologic, hepatic, renal, and neurological disease (as determined by physical examination and laboratory testing); * Demye…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Monetary Incentive Delay Task (MID)

Timeframe: Study visits: 1-3 days before intervention and 2 weeks post-intervention ]

Changes in Effort Based Decision Making Task (EBDM)

Timeframe: 1-3 days before intervention, 2 weeks post intervention

Changes in C-Reactive Protein (CRP)

Timeframe: Study Visits :1-3 days before intervention, 1 day post-intervention, 3 days, 1 week and 2 weeks post-intervention

Changes in Brief Negative Symptom Scale (BNSS)

Timeframe: 1-3 days before intervention, 1 day, 3 days, 1 week, and 2 weeks post intervention

Changes in Performance on the Effort Expenditure for Reward Task (EEfRT)

Timeframe: Study Visits :1-3 days before intervention and 2 weeks post intervention

Trial details

NCT IDNCT05823532

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03

Contact for this trial

David R Goldsmith, MD

404-727-3735 drgolds@emory.edu

View on ClinicalTrials.gov More Schizophrenia trials