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Tocilizumab for Schizophrenia

Phase 1

Recruiting

Led By Brian J Miller, MD

Research Sponsored by Brian Miller

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 baseline and 12 weeks

Awards & highlights

Study Summary

This trial is testing if tocilizumab, a medication used to treat arthritis, is effective and safe in treating patients with schizophrenia who also have evidence of increased inflammation.

Who is the study for?

This trial is for stable outpatients aged 18-55 with schizophrenia or schizoaffective disorder, not hospitalized in the past 3 months and on consistent psychotropic meds for over 4 weeks. Participants must have a DSM-V diagnosis, be taking non-clozapine antipsychotics, and show signs of inflammation (hsCRP >0.3 mg/dL). Exclusions include pregnancy, breastfeeding, recent drug use or antibiotics, immune disorders, certain medical conditions like ulcers or tuberculosis, abnormal blood counts or liver/renal function tests.Check my eligibility

What is being tested?

The study tests Tocilizumab's safety and effectiveness as an add-on to antipsychotic drugs in patients with schizophrenia showing increased inflammation. It's a randomized controlled trial where participants receive either Tocilizumab infusions every four weeks or placebo (normal saline) over a period of 12 weeks. The main goal is to see if Tocilizumab improves cognition compared to placebo.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site such as pain or swelling; increased risk of infections due to immune system suppression; changes in liver enzymes which could indicate liver issues; low neutrophil count that can increase infection risk; digestive tract problems like stomach ulcers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Cognition

Secondary outcome measures

Change in Total Psychotic Symptoms

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment GroupActive Control1 Intervention

Subjects in the tocilizumab group will receive a 4 mg/kg infusion at baseline, and weeks 4 and 8, as per the recommended starting dosing for rheumatoid arthritis

Group II: Control GroupPlacebo Group1 Intervention

Subjects in the placebo group will receive an infusion of normal saline (with the same packaging and volume as the tocilizumab group) at baseline, and weeks 4 and 8.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brain & Behavior Research FoundationOTHER

61 Previous Clinical Trials

2,794 Total Patients Enrolled

9 Trials studying Schizophrenia

331 Patients Enrolled for Schizophrenia

Brian MillerLead Sponsor

2 Previous Clinical Trials

38 Total Patients Enrolled

2 Trials studying Schizophrenia

38 Patients Enrolled for Schizophrenia

Brian J Miller, MDPrincipal InvestigatorAugusta University

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT02874573 — Phase 1

Schizophrenia Research Study Groups: Treatment Group, Control Group

Schizophrenia Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT02874573 — Phase 1

Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT02874573 — Phase 1

Frequently Asked Questions

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

What is the sample size of participants in this therapeutic experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively recruiting participants - the trial was first announced on September 1st 2016 and last updated July 27th 2021. They need 20 volunteers from a single site for its studies."

Answered by AI

Am I eligible to join this medical experiment?

"Only individuals with psychotic disorders between the ages of 18 and 55 are eligible to join this clinical trial. Slots for twenty prospective members remain available."

Answered by AI

What other exploratory studies have been undertaken involving Treatment Group?

"Presently, 71 studies are dedicated to Treatment Group with 8 of them in their final phase. The majority of these trials take place in Poznan and New york; however, there is presence across 1455 other locations too."

Answered by AI

What clinical indications are commonly addressed by Treatment Group?

"Treatment Group is the go-to treatment for polyarticular juvenile idiopathic arthritis, with potential applications to also treat patients suffering from systemic juvenile idiopathic arthritis (sjia), cytokine release syndrome caused by car-t cell therapy, and giant cells."

Answered by AI

Is there space available for participants in this research endeavor?

"Affirmative. Per clinicaltrials.gov, this research study is actively seeking participants and it was posted on September 1st 2016 with the last edit on July 27th 2021. The investigators are recruiting 20 individuals at a single site."

Answered by AI

Has Treatment Group acquired the necessary regulatory approvals from the FDA?

"The treatment group is estimated to be relatively safe, as it has only started initial phase 1 trials and there are not many safety data reports available yet. Therefore, a score of 1 was given."

Answered by AI