Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-31 @ 6:54 PM
Study NCT ID:
NCT05823532
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-Inflammatory Challenge in Schizophrenia
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Targeting Inflammation-Induced Changes in Brain Reward Signaling and Motivational Deficits in Patients With Schizophrenia Using an Anti-Inflammatory Challenge.
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
Study procedures include 9 separate visits as follows:
1. Pre-screening Visit which includes questions about mood and negative symptoms of schizophrenia, blood sampling to measure CRP which is a marker of inflammation, a urine drug screen (UDS) and urine testing for pregnancy in all biological women (approx. 1-2 hours).
2. Screening Visit which includes assessing for adverse events, more detailed questions about symptoms, a physical exam, blood draw for medical safety screening labs, magnetic resonance imaging (MRI) safety screening questionnaire, instruction and practice playing a computer game where the participant can earn money, and an electrocardiogram (EKG) to make sure the patient's heart is healthy.
3. Baseline Visit which includes assessing for adverse events, behavioral assessments, blood sampling for medical safety screening labs and research labs, functional magnetic resonance imaging (fMRI) scan where participant plays a computer game where s/he can earn extra money. Randomization to the study drug, Infliximab, or a placebo (approx. 5-6 hours).
4. Infusion Visit which includes assessing for adverse events, blood draw for safety screening labs, UDS and pregnancy testing, and infusion of the study drug, Infliximab, or a placebo (approx. 5 hours).
5. 24-hr Post Infusion Visit which includes behavioral assessments, vital signs, safety labs, and assessing for adverse events (approx. 1-2 hours).
6. 3-day Post Infusion Visit which includes assessing for adverse events, behavioral assessments, vital signs, safety labs (approx. 1-2 hours)
7. 7-day Post Infusion Visit which includes assessing for adverse events, behavioral assessments, vital signs and safety labs (approx. 1-2 hours)
8. 14-day Post Infusion Visit which includes assessing for adverse events, blood draw for safety labs, urine pregnancy and drug testing, fMRI scan and a lumbar puncture for cerebrospinal fluid (CSF)(approx. 6-7 hours)
9. One-month Follow-up Safety Check-in which includes a phone call to assess for adverse (approx. 10-15 minutes).
Approximately 60 subjects will be consented and prescreened in order to obtain complete data on 20 medically stable, male, and female adult subjects with schizophrenia or schizoaffective disorder at the Grady Behavioral Health Clinic.
Blood will be collected across multiple visits, some of which will be stored for future research use.
Written informed consent will be obtained in a private office at the Grady Behavioral Health Clinic. All aspects of the study will be reviewed and a discussion will occur to make sure the participant is aware of all study details. Should a subject agree to study participation, s/he will be given a copy of the informed consent for their records. In addition, the process of informed consent will continue throughout the course of each study visit to be sure the participant is fully aware of all procedures. If the participant has a legally authorized representative (LAR), the LAR will be required to attend the initial prescreening visit and sign the informed consent.
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.
Study procedures include 9 separate visits as follows:
1. Pre-screening Visit which includes questions about mood and negative symptoms of schizophrenia, blood sampling to measure CRP which is a marker of inflammation, a urine drug screen (UDS) and urine testing for pregnancy in all biological women (approx. 1-2 hours).
2. Screening Visit which includes assessing for adverse events, more detailed questions about symptoms, a physical exam, blood draw for medical safety screening labs, magnetic resonance imaging (MRI) safety screening questionnaire, instruction and practice playing a computer game where the participant can earn money, and an electrocardiogram (EKG) to make sure the patient's heart is healthy.
3. Baseline Visit which includes assessing for adverse events, behavioral assessments, blood sampling for medical safety screening labs and research labs, functional magnetic resonance imaging (fMRI) scan where participant plays a computer game where s/he can earn extra money. Randomization to the study drug, Infliximab, or a placebo (approx. 5-6 hours).
4. Infusion Visit which includes assessing for adverse events, blood draw for safety screening labs, UDS and pregnancy testing, and infusion of the study drug, Infliximab, or a placebo (approx. 5 hours).
5. 24-hr Post Infusion Visit which includes behavioral assessments, vital signs, safety labs, and assessing for adverse events (approx. 1-2 hours).
6. 3-day Post Infusion Visit which includes assessing for adverse events, behavioral assessments, vital signs, safety labs (approx. 1-2 hours)
7. 7-day Post Infusion Visit which includes assessing for adverse events, behavioral assessments, vital signs and safety labs (approx. 1-2 hours)
8. 14-day Post Infusion Visit which includes assessing for adverse events, blood draw for safety labs, urine pregnancy and drug testing, fMRI scan and a lumbar puncture for cerebrospinal fluid (CSF)(approx. 6-7 hours)
9. One-month Follow-up Safety Check-in which includes a phone call to assess for adverse (approx. 10-15 minutes).
Approximately 60 subjects will be consented and prescreened in order to obtain complete data on 20 medically stable, male, and female adult subjects with schizophrenia or schizoaffective disorder at the Grady Behavioral Health Clinic.
Blood will be collected across multiple visits, some of which will be stored for future research use.
Written informed consent will be obtained in a private office at the Grady Behavioral Health Clinic. All aspects of the study will be reviewed and a discussion will occur to make sure the participant is aware of all study details. Should a subject agree to study participation, s/he will be given a copy of the informed consent for their records. In addition, the process of informed consent will continue throughout the course of each study visit to be sure the participant is fully aware of all procedures. If the participant has a legally authorized representative (LAR), the LAR will be required to attend the initial prescreening visit and sign the informed consent.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01MH131910-01 | NIH | None | https://reporter.nih.gov/quic… | View |