clozapine for Schizophrenia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Schizophrenia+4 More
clozapine - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

This trial is designed to study the effects of the medication clozapine on people with psychosis, including schizophrenia, schizoaffective disorder, and psychotic bipolar I disorder. The trial will compare the effects of clozapine to a control group taking risperidone. The study sample will be comprised of n=524 individuals with psychosis, who will be randomly assigned to either the clozapine group or the control group. The investigators plan to follow the participants for a biomedical outcome.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder
  • Bipolar Disorder

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Schizophrenia

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Week 4, Week 10 and Week 18

Week 18
Change in the PANSS total score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Schizophrenia

Trial Design

4 Treatment Groups

Biotype 2 - Clozapine (B2C)
1 of 4
Biotype 1 - Clozapine (B1C)
1 of 4
Biotype 1 - Risperidone (B1R)
1 of 4
Biotype 2 - Risperidone (B2R)
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

524 Total Participants · 4 Treatment Groups

Primary Treatment: clozapine · Has Placebo Group · Phase 4

Biotype 1 - Clozapine (B1C)
Drug
Experimental Group · 1 Intervention: clozapine · Intervention Types: Drug
Biotype 1 - Risperidone (B1R)
Drug
PlaceboComparator Group · 1 Intervention: risperidone · Intervention Types: Drug
Biotype 2 - Clozapine (B2C)
Drug
ActiveComparator Group · 1 Intervention: clozapine · Intervention Types: Drug
Biotype 2 - Risperidone (B2R)
Drug
PlaceboComparator Group · 1 Intervention: risperidone · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clozapine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 4, week 10 and week 18

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterOTHER
772 Previous Clinical Trials
848,029 Total Patients Enrolled
19 Trials studying Schizophrenia
1,168 Patients Enrolled for Schizophrenia
Hartford HospitalOTHER
117 Previous Clinical Trials
16,429 Total Patients Enrolled
3 Trials studying Schizophrenia
286 Patients Enrolled for Schizophrenia
University of ChicagoOTHER
917 Previous Clinical Trials
741,823 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,522 Previous Clinical Trials
1,814,066 Total Patients Enrolled
227 Trials studying Schizophrenia
86,330 Patients Enrolled for Schizophrenia
University of GeorgiaOTHER
83 Previous Clinical Trials
27,789 Total Patients Enrolled
1 Trials studying Schizophrenia
70 Patients Enrolled for Schizophrenia
University of Texas Southwestern Medical CenterLead Sponsor
943 Previous Clinical Trials
605,658 Total Patients Enrolled
8 Trials studying Schizophrenia
2,641 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: October 1st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.