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Anti-Inflammatory Challenge in Schizophrenia

StatusRecruiting
PhasePhase 4
Started2024-04-18
View on ClinicalTrials.gov ↗

Amendment history

2026-06-01
minor
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v6
Enrollment target20→60
Eligibility criteria+2 characters
Inclusion Criteria: Men or women, 18-4555 years of age with a primary diagnosis of Diagnostic and Sta [...] lling and able to give written informed consent; Plasma CRP 3mg≥2 mg/L; Significant motivational deficit as reflected by a score [...]
Secondary endpoints14 to 10 entries
Changes in Performance on the Effort Expenditure for Reward Task Changes in Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form Changes in The Calgary Depression Scale for Schizophrenia (CDSS) Changes in WHO Disability Assessment Schedule (WHODAS)
Primary endpoints4 to 5 entries
Changes in Performance on the Effort Expenditure for Reward Task (EEfRT)
Study description-311 characters
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 [...] Schizophrenia is a chronic and disabling mental illness that affects over 20 million people globally. One of its most debilitating aspects is a group of symptoms known as negative symptoms, which include reduced motivation, pleasure, and social engagement. Among these, amotivation-or the lack of dri [...] [...]
Study sitesdetails revised at 1 of 2 sites
2024-04-26
minor
Study Status, Eligibility, Contacts/Locations v5
Start dateestimated 2024-03→confirmed 2024-04-18
Eligibility criteria-21 characters
[...] ection; History of recurrent viral or bacterial infections; Evidence of untreated or poorly controlled endocrine,Unstable cardiovascular (including evidence of congestive heart fail [...] determined by physical examination and laboratory testing), hematologicalendocrinologic, hematologic, hepatic, renal, orand neurological disease (as determined by physical examination [...]
Study sitesdetails revised at 1 of 2 sites
2024-02-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start date2024-01→2024-03
Study sitesdetails revised at 2 of 2 sites
2023-12-20
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v3
Start date2023-11→2024-01
Eligibility criteria-117 characters
[...] will be conducted at 2-week intervals as per American Heart associationAssociation/ Center for Disease and Control Prevention guidelines to es [...] nfection (along with physical exam and laboratory testing). Subjects may be taking psychotropic medications at the time of the study (including antipsychotics, antidepressants, mood stabilizers, benzodiazepines) but may have no psychotropic medication changes for one month prior to study enrollment. Patients must also have a negative urine drug screen at all [...] ection; History of recurrent viral or bacterial infections; UnstableEvidence of untreated or poor [...] [...]
Secondary endpoints14 entries, revised
Changes in Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form
Study sitescontacts updated at 2 of 2 sites
2023-10-13
minor
Study Identification, Study Status, Sponsor/Collaborators v2
Start date2023-08→2023-11
Collaborators+42 characters
National Institute of Mental Health (NIMH)
2023-05-09
minor
Study Status v1
Start date2023-04→2023-08
2023-04-10
minor
Original filing
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.
Trial Details
NCT Number NCT05823532
Lead Sponsor Emory University
Collaborators: National Institute of Mental Health (NIMH)
Conditions Schizophrenia
Enrollment 60 participants
Start Date 2024-04-18
Primary Completion 2028-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2026-06-03