clozapine for Schizophrenia
Phase-Based Progress Estimates
Effectiveness
Safety
Schizophrenia+4 More
clozapine - DrugEligibility
18 - 65
All Sexes
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Eligibility
18 - 65
All Sexes
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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
This is further along than 93% of similar trials
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
This is further along than 85% of similar trials
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: DrugBiotype 1 - Risperidone (B1R)
Drug
PlaceboComparator Group · 1 Intervention: risperidone · Intervention Types: DrugBiotype 2 - Clozapine (B2C)
Drug
ActiveComparator Group · 1 Intervention: clozapine · Intervention Types: DrugBiotype 2 - Risperidone (B2R)
Drug
PlaceboComparator Group · 1 Intervention: risperidone · Intervention Types: DrugTreatment
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
Mark “yes” if the following statements are true for you:About The Reviewer
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.
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