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Anti-inflammatory Agent
Infliximab for Schizophrenia
Phase 4
Recruiting
Led By David R Goldsmith, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study visits :1-3 days before intervention, 1 week and 2 weeks post-intervention
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will investigate the effects of an anti-inflammatory drug on negative symptoms of schizophrenia, with the goal of identifying new treatments.
Who is the study for?
This trial is for men and women aged 18-45 with schizophrenia or schizoaffective disorder, who have high inflammation levels and severe motivational deficits. Participants must not have any autoimmune disorders, active infections like TB or hepatitis, cancer history, unstable diseases, substance abuse within the last six months, or be on certain medications.
What is being tested?
The study tests if a single infusion of infliximab (an anti-inflammatory drug) can improve negative symptoms in schizophrenia patients with high inflammation compared to a placebo. There are two groups: one receiving infliximab and the other a placebo.
What are the potential side effects?
Infliximab may cause side effects such as risk of infection, allergic reactions to its components (since it's derived from mouse proteins), potential liver issues, and could affect blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study visits :1-3 days before intervention,3 days post intervention, 1 week and 2 weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study visits :1-3 days before intervention,3 days post intervention, 1 week and 2 weeks post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Brief Negative Symptom Scale (BNSS)
Changes in C-Reactive Protein (CRP)
Changes in Effort Based Decision Making Task (EBDM)
+1 moreSecondary study objectives
Changes in Calgary Depression Scale for Schizophrenia (CDSS)
Changes in Inflammatory markers changes: IL-1
Changes in Inflammatory markers changes: IL-10
+11 moreSide effects data
From 2020 Phase 4 trial • 42 Patients • NCT0300639352%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Nausea
10%
Change in urination
10%
Heartburn
10%
Fatigue
10%
Dizziness
10%
Itchiness
5%
Pain in joints
5%
Chest pain
5%
Stomach ache
5%
Syncope
5%
Menstruation
5%
Migraine
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InfliximabExperimental Treatment1 Intervention
Subjects will be stratified by sex and randomized prior to this visit in preparation for the infusion. Vitals and safety labs will be drawn at this visit as well as urine testing for drugs of abuse and pregnancy testing for all biological females. Patients will receive breakfast followed by a double-blinded infusion of infliximab (5mg/kg body weight) in the GCSTA Clinical Research Center at Emory University Hospital. The infusion will last 3 hours, and subjects will be monitored during the infusion and for one hour after completion for the possible development of anaphylaxis, which occurs in less than 1% of patients receiving an initial dose of infliximab
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be stratified by sex and randomized prior to this visit in preparation for the infusion. Vitals and safety labs will be drawn at this visit as well as urine testing for drugs of abuse and pregnancy testing for all biological females. Patients will receive breakfast followed by a double-blinded infusion of saline in the GCSTA Clinical Research Center at Emory University Hospital. The infusion will last 3 hours, and subjects will be monitored during the infusion and for one hour after completion for the possible development of anaphylaxis, which occurs in less than 1% of patients receiving an initial dose of infliximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
2017
Completed Phase 4
~3350
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,896 Total Patients Enrolled
254 Trials studying Schizophrenia
90,011 Patients Enrolled for Schizophrenia
Emory UniversityLead Sponsor
1,700 Previous Clinical Trials
2,604,578 Total Patients Enrolled
9 Trials studying Schizophrenia
932 Patients Enrolled for Schizophrenia
David R Goldsmith, MDPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer before.I am not taking NSAIDs or glucocorticoids during the study.I haven't taken steroids, immunosuppressants, or other immune-targeting drugs in the last 6 months.I have been diagnosed with a mood or anxiety disorder like depression, bipolar, or PTSD.I am a woman who can have children and am not using birth control.I cannot have an MRI but my main diagnosis is schizophrenia.I have a brain condition affecting the protective covering of nerves.I do not have untreated or poorly controlled heart, kidney, blood, hormone, or nerve conditions.I am not taking clozapine due to its risks.I often get viral or bacterial infections.I have had an organ transplant.I have not received any live vaccines within a month before or will not during the study.I am on stable mental health medications with no changes in the last month.I am between 18-45 years old and diagnosed with schizophrenia or schizoaffective disorder.I haven't taken NSAIDs, steroids, minocycline, or anti-inflammatory supplements recently.
Research Study Groups:
This trial has the following groups:- Group 1: Infliximab
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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