280 Participants Needed

Clozapine for Schizophrenia

(REVISIT-C Trial)

Recruiting at 6 trial locations
RG
Overseen ByRagy Girgis
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: New York State Psychiatric Institute
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you can participate if you are currently medication-free or on any antipsychotic, except clozapine or long-acting injectables with a dosing interval of more than 30 days.

What data supports the effectiveness of the drug Clozapine for schizophrenia?

Clozapine is considered the most effective drug for managing treatment-resistant schizophrenia, showing significant improvement in symptoms compared to other second-generation antipsychotic drugs, especially in patients who have not responded well to at least two other antipsychotic medications.12345

Is clozapine safe for use in humans?

Clozapine is generally safe for humans when used carefully, but it can have serious side effects like blood problems, heart issues, and seizures. Regular monitoring of blood cells and other health checks are important to manage these risks.678910

What makes the drug clozapine unique for treating schizophrenia?

Clozapine is unique because it is the only antipsychotic drug specifically approved for treatment-resistant schizophrenia, meaning it is used when other treatments have failed. It is also known for having fewer movement-related side effects compared to traditional antipsychotic drugs.211121314

What is the purpose of this trial?

This trial is testing whether clozapine can reduce violent behavior more effectively than usual treatments in adults with schizophrenia who have recently been violent. Clozapine helps by balancing brain chemicals to manage symptoms. The study will last for several months and include regular medical check-ups. Clozapine has been shown to reduce violent and aggressive behavior in patients with schizophrenia, especially those who are treatment-resistant.

Research Team

RG

Ragy R Girgis, MD

Principal Investigator

New York State Psychiatric Institute

Eligibility Criteria

This trial is for adults with schizophrenia or schizoaffective disorder who have been violent recently. They must be medically stable, able to consent, and not on certain long-term medications. Pregnant women, those intolerant to clozapine, with serious medical conditions or high suicide risk are excluded.

Inclusion Criteria

Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of schizophrenia or schizoaffective disorder by the Structured Clinical Interview for DSM-5 (SCID-5)
medically stable in judgment of physician providing study treatment
You have committed a violent act in the past six months, as determined by the MCVI assessment.
See 2 more

Exclusion Criteria

A history of intolerance/allergy to clozapine (e.g., agranulocytosis, small bowel obstruction, or myocarditis)
I do not have a serious condition affecting my blood or nervous system.
I tried clozapine without success or had side effects.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with clozapine or treatment as usual (TAU) for 24 weeks

24 weeks
Regular visits for assessments and medical monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Clozapine
  • Treatment as Usual
Trial Overview The study compares the effectiveness of clozapine versus usual antipsychotic treatments in reducing violence among individuals with schizophrenia over a 24-week period across seven sites. Participants will be randomly assigned to one of the two treatment groups.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ClozapineExperimental Treatment1 Intervention
treatment with clozapine naturalistically administered (as per clinical guideline).
Group II: Treatment as usualActive Control1 Intervention
open label naturalistic treatment as usual with any antipsychotic other than clozapine

Clozapine is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Clozaril for:
  • Schizophrenia
  • Borderline Personality Disorder
  • Paranoid Disorder
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Clozapine for:
  • Schizophrenia
  • Treatment-resistant schizophrenia

Find a Clinic Near You

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials
481
Recruited
154,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

Clozapine is ineffective for over 50% of treatment-resistant schizophrenia patients, and while adjunctive treatments like amisulpride, aripiprazole, and mirtazapine show some evidence of efficacy, overall data on safety and effectiveness for these strategies is limited.
Meta-analyses indicated that risperidone and lamotrigine do not support their use as adjuncts to clozapine, highlighting the need for further research due to small sample sizes and variability in study designs.
Clozapine resistance: augmentation strategies.Porcelli, S., Balzarro, B., Serretti, A.[2022]
A study involving 28 Korean patients with schizophrenia found that the generic formulation of clozapine (Clzapine) is bioequivalent to the brand name formulation (Clozaril), showing similar pharmacokinetic profiles in terms of peak concentration and overall drug exposure.
Both formulations had comparable safety profiles, with no significant differences in adverse events, vital signs, or laboratory tests, suggesting that Clzapine can be a safe alternative to Clozaril for treating refractory schizophrenia.
Bioequivalence of Generic and Brand Name Clozapine in Korean Schizophrenic Patients: A Randomized, Two-Period, Crossover Study.Woo, YS., Wang, HR., Yoon, BH., et al.[2020]
A study involving 26 Chinese patients with schizophrenia found that the generic formulation of clozapine is bioequivalent to the brand-name Clozaril, meaning they produce similar plasma drug concentrations after multiple doses.
Both formulations resulted in a comparable number of adverse events, indicating that the safety profile of the generic clozapine is similar to that of the brand-name version.
Evaluation of bioequivalence between generic and brand-name clozapine in Chinese schizophrenic patients: A randomized, two-period, crossover study.Yang, X., Yan, Q., Yang, L., et al.[2021]

References

Clozapine resistance: augmentation strategies. [2022]
Bioequivalence of Generic and Brand Name Clozapine in Korean Schizophrenic Patients: A Randomized, Two-Period, Crossover Study. [2020]
Evaluation of bioequivalence between generic and brand-name clozapine in Chinese schizophrenic patients: A randomized, two-period, crossover study. [2021]
CYP2C19*17 protects against metabolic complications of clozapine treatment. [2022]
Randomized controlled trial of effect of prescription of clozapine versus other second-generation antipsychotic drugs in resistant schizophrenia. [2022]
Clozapine is the approved option in treatment-resistant schizophrenia and requires careful management. [2023]
Clozapine Monitoring in Clinical Practice: Beyond the Mandatory Requirement. [2022]
A review of clozapine safety. [2013]
Monitoring the safe use of clozapine: a consensus view from Victoria, Australia. [2018]
Clozapine Management in Schizophrenia Inpatients: A 5-Year Prospective Observational Study of Its Safety and Tolerability Profile. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Update on the clinical efficacy and side effects of clozapine. [2022]
Clozapine. [2016]
A systematic review and meta-analysis of the association between clozapine and norclozapine serum levels and peripheral adverse drug reactions. [2021]
Adherence to treatment guidelines in clinical practice: study of antipsychotic treatment prior to clozapine initiation. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity