Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial will compare Clozapine to other antipsychotic drugs to see if Clozapine reduces inflammation, which might explain its effectiveness in treating schizophrenia and reducing suicide risk.
Who is the study for?
This trial is for individuals aged 18-40 with treatment-refractory schizophrenia, who are physically healthy and can consent to the study. Participants will either start Clozapine or continue non-Clozapine antipsychotics. Exclusions include significant medical conditions, recent infections, chronic viral infections, autoimmune diseases, past Clozapine use within 6 months, immunomodulatory therapy use, recent vaccinations, substance abuse disorders, pregnancy or intellectual disability.
What is being tested?
The trial aims to compare the effects of Clozapine versus other antipsychotics on inflammatory markers in people with hard-to-treat schizophrenia. It explores whether starting Clozapine reduces levels of interleukin-6 among other markers and assesses its impact on psychosis and suicidality.
What are the potential side effects?
Clozapine may cause side effects like inflammation due to immune response changes; it's also known for potential blood disorders (agranulocytosis), sedation, increased heart rate (tachycardia), digestive issues (constipation), and seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Interleukin-6 (IL-6)
Secondary study objectives
Other immune/cardiac markers
Positive and Negative Syndrome symptom Scale
Self-injurious Thoughts and Behaviors Interviews
Side effects data
From 2008 Phase 4 trial • 25 Patients • NCT0000165670%
tachycardia >100 beats/min (supine)
67%
Hypersalivation
64%
Hypertension
42%
Enuresis
33%
Increased appetite
33%
Difficulty concentrating
25%
Insomnia
17%
Abnormal white blood count
17%
Somnolence
17%
Constipation
10%
Tachycardia >120 beats/min (supine)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clozapine Group
Olanzapine Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Active Control
Group I: Clozapine ArmExperimental Treatment1 Intervention
Patients will be on Clozapine for at least 6 months
Group II: Non-Clozapine armActive Control1 Intervention
Patients will be on non-Clozapine antipsychotic for at least 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clozapine
2000
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
866 Previous Clinical Trials
655,101 Total Patients Enrolled
2 Trials studying Schizophrenia
280 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking lithium.I am physically healthy with no major unstable health conditions.I have a history of autoimmune or chronic inflammatory conditions.I have been vaccinated in the last 3 months.I have taken Clozapine in the last 6 months.I am currently on medication that affects my immune system or reduces inflammation.I am between 18 and 65 years old.I've been on a non-Clozapine antipsychotic for 6+ months and haven't tried Clozapine for specific reasons.I have a serious heart, lung, hormone, or kidney condition needing ongoing treatment.My schizophrenia has not improved with treatment.I have been taking Clozapine for at least 6 months.I have not had a bacterial or viral infection in the last 4 weeks.I have a chronic viral infection like hepatitis or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Clozapine Arm
- Group 2: Non-Clozapine arm
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger