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Clozapine for Schizophrenia

Phase 4

Recruiting

Research Sponsored by Ohio State University

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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interleukin-6 (IL-6)

Secondary outcome measures

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 • NCT00001656

31%

Increased appetite

31%

Hypersalivation

17%

tachycardia >100 beats/min (supine)

15%

Somnolence

15%

Constipation

Hypertension

Difficulty concentrating

Insomnia

Enuresis

Abnormal white blood count

100%

80%

60%

40%

20%

Study treatment Arm

Olanzapine Group

Clozapine Group

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,683 Total Patients Enrolled

2 Trials studying Schizophrenia

280 Patients Enrolled for Schizophrenia

Media Library

Antipsychotics,Other (non-Clozapine) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05741502 — Phase 4

Schizophrenia Research Study Groups: Clozapine Arm, Non-Clozapine arm

Schizophrenia Clinical Trial 2023: Antipsychotics,Other (non-Clozapine) Highlights & Side Effects. Trial Name: NCT05741502 — Phase 4

Antipsychotics,Other (non-Clozapine) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05741502 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals under the age of 45 eligible to participate in this trial?

"According to the requirements, potential participants must be aged 18-40. Otherwise, there are 47 trials available for patients younger than 18 and another 177 studies that accommodate those older than 65."

Answered by AI

Has Clozapine Arm been given clearance by the FDA?

"The safety of the Clozapine Arm was deemed to be a 3, as it is currently in Phase 4 clinical trials and has already been approved."

Answered by AI

Who is eligible to participate in this trial?

"This clinical study is recruiting 60 individuals diagnosed with treatment-resistant schizophrenia, aged between 18 and 40. To be eligible for the trial, participants must have no significant medical conditions hindering their health as confirmed by a physical examination; they should also provide informed consent and belong to either Clozapine (n=30) or non-Clozapine comparator group (n=30). The latter requires that patients are currently undergoing antipsychotic treatments but would opt out of utilizing Clozapine due to personal reasons."

Answered by AI

Are more participants being taken on for this experiment?

"According to the clinicaltrials.gov page, this particular medical study is not actively recruiting patients at present. The trial was initially posted on March 20th of 2021 and has seen its last update take place on February 22nd of 2020; nevertheless, there are 339 additional trials requiring participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

Walter Stearns 2023. "An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05741502.

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