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Infliximab for Motivational Deficits in Schizophrenia
NCT05823532Phase 4
Key facts
- Status
- Recruiting
- Start
- Apr 2024
- Primary completion
- Mar 2028
- Countries
- 1
- Sponsor
- Emory University
- Modality
- Monoclonal Antibodies
- Drugs
- infliximab
- Conditions
- schizophreniaschizoaffective disorder
01
Overview
Phase 4, randomised, double-blind trial in schizophrenia and schizoaffective disorder comparing Infliximab with Placebo (2 arms). Primary endpoints: Monetary Incentive Delay Task, Effort Based Decision Making Task and 3 more. Started Apr 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Infliximab
Double-blinded infusion of infliximab (5mg/kg body weight)
Placebo
Double-blinded infusion of saline
03
Who it enrols
Adults aged 18-55 with schizophrenia or schizoaffective disorder, elevated CRP (>=2 mg/L), and significant motivational deficits, excluding those with active infections, autoimmune disorders, recent substance abuse, or taking certain immunosuppressive or anti-inflammatory medications.
04
Endpoints
Primary
Monetary Incentive Delay Task
Effort Based Decision Making Task
C-Reactive Protein
Brief Negative Symptom Scale
Effort Expenditure for Reward Task
Secondary
Positive and Negative Syndrome Scale
Motivation and Pleasure Scale
Calgary Depression Scale for Schizophrenia
Interleukin-1
Interleukin-6
Interleukin-10
Soluble Interleukin-6 Receptor
Tumor Necrosis Factor
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