Actively Recruiting
Anti-Inflammatory Challenge in Schizophrenia
Led by Emory University · Updated on 2024-04-30
20
Participants Needed
2
Research Sites
201 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research project will explore negative symptoms of schizophrenia, such as motivational deficits, by examining the relationship between inflammation and reward-related brain regions. To accomplish this, we will administer a single infusion of either the anti-inflammatory medication infliximab or placebo (n=10 per group) to patients with high inflammation. This study is important because schizophrenia can be a chronic and debilitating neuropsychiatric disorder and negative symptoms are some of the most difficult aspects of schizophrenia associated with worst functional outcomes. These symptoms do not typically respond to antipsychotic therapies, and as such, there are no current medications to treat negative symptoms.
CONDITIONS
Official Title
Anti-Inflammatory Challenge in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women, 18-45 years of age with a primary diagnosis of DSM-V schizophrenia or schizoaffective disorder
- Willing and able to give written informed consent
- Plasma C-Reactive Protein (CRP) level of 3 mg/L or higher
- Significant motivational deficit with a score greater than 17 on the Motivation and Pleasure Domain of the Brief Negative Symptom Scale
- Negative urine drug screen at all study visits
You will not qualify if you...
- Any autoimmune disorder confirmed by lab testing
- History of tuberculosis infection or high risk of exposure
- Active hepatitis B, hepatitis C, or HIV infection
- History of any type of cancer
- History of fungal infections
- History of recurrent viral or bacterial infections
- Unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurological disease
- Demyelinating brain disease or concerning MRI abnormalities
- Substance abuse or dependence within 6 months before study entry
- Primary diagnosis of major mood or anxiety disorder
- Active suicidal thoughts or plans
- Active eating disorder
- History of cognitive disorder or Mini-Mental State Exam score less than 24
- Pregnancy or breastfeeding
- Treatment with clozapine
- Women of childbearing potential not using medically accepted contraception
- Known allergy to murine products or biologic therapies
- Previous organ transplant
- Live virus vaccine use within one month before, during, or one month after study
- Use of oral glucocorticoids, immunosuppressive drugs, or immune-targeting drugs within 6 months before baseline
- Chronic use of NSAIDs (except low-dose aspirin), glucocorticoid medications, minocycline, or anti-inflammatory supplements within 2 weeks before baseline or during study
- Use of NSAIDs or glucocorticoids at any time during study
- Any contraindication to MRI
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Not Yet Recruiting
2
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
D
David R Goldsmith, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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