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Atypical Antipsychotic
Clozapine vs Risperidone for Psychosis
Phase 4
Recruiting
Led By Carol Tamminga, M.D.
Research Sponsored by University of Texas Southwestern Medical Center
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
Must not have
Neurological conditions such as seizure disorder, stroke, traumatic brain injury with a loss of consciousness ≥ 30min, or severe medical conditions such as decompensated cardiovascular disorder, AIDS, that may affect central nervous system function
History of neuroleptic malignant syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 10 and week 18
Awards & highlights
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.
Who is the study for?
This trial is for adults aged 18-60 with schizophrenia, schizoaffective disorder, or bipolar I with psychotic features. Participants must be medically stable, have a certain level of symptom severity, and not belong to vulnerable groups like pregnant women. They shouldn't have used clozapine before or certain long-acting antipsychotics recently.
What is being tested?
The study compares the effects of clozapine versus risperidone on individuals with specific types of psychosis. It's a rigorous test where participants are randomly assigned to one of the drugs in a controlled environment across multiple sites to see which drug works better for their condition.
What are the potential side effects?
Clozapine can cause side effects such as drowsiness, increased saliva production, constipation, and potentially serious blood disorders. Risperidone may lead to movement disorders, weight gain, fatigue and an increased risk for diabetes.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe neurological or medical conditions affecting my brain.
Select...
I have had neuroleptic malignant syndrome in the past.
Select...
I've had severe side effects or no improvement with clozapine or risperidone.
Select...
I am not taking medications that significantly affect brain wave tests or cannot be stopped safely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4, week 10 and week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 10 and week 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in the PANSS total score
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Biotype 1 - Clozapine (B1C)Experimental Treatment1 Intervention
Target doses will be up to clozapine 500mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at bedtime\], hydroxyzine \[up to 100mg at bedtime\]; benztropine \[up to 4mg/day (2mg twice/day)\], propranolol \[up to 40mg/day (20mg twice/day)\].
Group II: Biotype 2 - Clozapine (B2C)Active Control1 Intervention
Target doses will be up to clozapine 500mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at bedtime\], hydroxyzine \[up to 100mg at bedtime\]; benztropine \[up to 4mg/day (2mg twice/day)\], propranolol \[up to 40mg/day (20mg twice/day)\].
Group III: Biotype 1 - Risperidone (B1R)Placebo Group1 Intervention
Target doses will be up to risperidone 6mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at bedtime\], hydroxyzine \[up to 100mg at bedtime\]; benztropine \[up to 4mg/day (2mg twice/day)\], propranolol \[up to 40mg/day (20mg twice/day)\].
Group IV: Biotype 2 - Risperidone (B2R)Placebo Group1 Intervention
Target doses will be up to risperidone 6mg po qd. In addition, several concomitant (open label) medications for symptomatic management will be available via the study protocol \[non-benzodiazepine sleep aid (melatonin, hydroxyzine); motor side effect treatments (benztropine, propranolol)\]. The doses for these medications will be consistent with those routinely used in a clinical practice: melatonin \[up to 10mg at bedtime\], hydroxyzine \[up to 100mg at bedtime\]; benztropine \[up to 4mg/day (2mg twice/day)\], propranolol \[up to 40mg/day (20mg twice/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
clozapine
2006
N/A
~20
Find a Location
Who is running the clinical trial?
University of GeorgiaOTHER
102 Previous Clinical Trials
44,224 Total Patients Enrolled
1 Trials studying Schizophrenia
70 Patients Enrolled for Schizophrenia
Hartford HospitalOTHER
138 Previous Clinical Trials
18,873 Total Patients Enrolled
3 Trials studying Schizophrenia
262 Patients Enrolled for Schizophrenia
University of Texas Southwestern Medical CenterLead Sponsor
1,072 Previous Clinical Trials
1,055,738 Total Patients Enrolled
8 Trials studying Schizophrenia
2,641 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a severe allergic reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Drug-Induced Hypersensitivity Syndrome (DIHS) in the past.I do not have severe neurological or medical conditions affecting my brain.I am between 18 and 60 years old.You are currently having thoughts about hurting someone and have a detailed plan on how to do it, which means you cannot receive treatment as an outpatient.My health condition is currently stable.You are not willing to use a reliable method of birth control.I have had neuroleptic malignant syndrome in the past.You have a high score on a test that measures symptoms of mental illness, specifically the PANSS test.I've had severe side effects or no improvement with clozapine or risperidone.You have been diagnosed with schizophrenia, schizoaffective disorder, or bipolar I disorder with psychotic features according to specific guidelines.I am not taking medications that significantly affect brain wave tests or cannot be stopped safely.I have not taken clozapine or long-acting injectable antipsychotics recently.You have been diagnosed with alcohol or drug abuse in the past month, or drug dependence in the past three months.
Research Study Groups:
This trial has the following groups:- Group 1: Biotype 1 - Clozapine (B1C)
- Group 2: Biotype 1 - Risperidone (B1R)
- Group 3: Biotype 2 - Clozapine (B2C)
- Group 4: Biotype 2 - Risperidone (B2R)
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT04580134 — Phase 4
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