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Siltuximab for Schizophrenia

Phase 1 & 2
Recruiting
Research Sponsored by Brian Miller
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Taking a non-clozapine antipsychotic
Diagnosis of schizophrenia or schizoaffective disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 9 weeks
Awards & highlights

Study Summary

This trial is testing if siltuximab is an effective and safe treatment for patients with schizophrenia who also have evidence of increased inflammation. Siltuximab is a recombinant chimeric (human-murine) anti-human interleukin-6 (IL-6) monoclonal antibody that is given as an intravenous infusion.

Who is the study for?
This trial is for stable outpatients with schizophrenia or schizoaffective disorder who have been on the same psychotropic meds for over 4 weeks and show signs of inflammation (hsCRP >0.3 mg/dL). Excluded are those with certain medical conditions, recent drug use, immune disorders, abnormal blood counts or liver/renal function tests, active infections, pregnant or breastfeeding women not using contraception.Check my eligibility
What is being tested?
The study tests Siltuximab's safety and effectiveness as an add-on to antipsychotic drugs in patients with schizophrenia. It's a Phase 1 trial where participants receive intravenous infusions of Siltuximab every three weeks to see if it improves cognition compared to a saline placebo.See study design
What are the potential side effects?
Potential side effects of Siltuximab may include reactions at the infusion site, increased risk of infection due to immune system suppression, gastrointestinal issues like ulcers or diverticulitis, and possible impacts on liver and kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are currently not taking a medication called clozapine for your mental health.
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You have been diagnosed with schizophrenia or schizoaffective disorder.
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Your health condition is considered stable according to the doctor's evaluation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 9 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 9 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 siltuximab group will receive an 11 mg/kg infusion at baseline, and weeks 3 and 6, as per the recommended dosing for multicentric Castleman's disease
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 siltuximab group) at baseline, and weeks 3 and 6.

Find a Location

Who is running the clinical trial?

Brian MillerLead Sponsor
2 Previous Clinical Trials
28 Total Patients Enrolled
2 Trials studying Schizophrenia
28 Patients Enrolled for Schizophrenia
Stanley Medical Research InstituteOTHER
140 Previous Clinical Trials
10,366 Total Patients Enrolled
83 Trials studying Schizophrenia
6,316 Patients Enrolled for Schizophrenia

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT02796859 — Phase 1 & 2
Schizophrenia Research Study Groups: Treatment Group, Control Group
Schizophrenia Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT02796859 — Phase 1 & 2
Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT02796859 — Phase 1 & 2

Frequently Asked Questions

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

Who are the qualified participants for this experiment?

"This clinical trial seeks around 30 participants, aged between 18 and 55 years old, who have a diagnosis of schizophrenia."

Answered by AI

Are there any antecedent studies that have focused on Treatment Group?

"Presently, 4 active studies are exploring Treatment Group. Of these trials, none have reached Phase 3 yet. Most of the clinical trials for Treatment Group take place in New york City; however there are 6 other sites conducting similar research."

Answered by AI

How many volunteers are participating in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this medical experiment is presently looking for participants and was first listed in May of 2016 with a most recent update in July 2021. The study requires 30 patients to be recruited from one location."

Answered by AI

Is this experiment open to participants who are more than thirty years of age?

"The specified age range for this medical trial is 18 to 55. However, there are 137 trials available for minors and 366 trials specifically geared towards seniors."

Answered by AI

Are there any opportunities for participants to join this experiment?

"According to information published on clinicaltrials.gov, this medical study is currently accepting participants. This trial was first announced in May 2016 and saw its latest update take place a few months ago - July 2021."

Answered by AI
Recent research and studies
~3 spots leftby Mar 2025