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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

Drug Has Already Been Approved

Pivotal Trial

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:

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I do not have severe neurological or medical conditions affecting my brain.

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I have had neuroleptic malignant syndrome in the past.

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I've had severe side effects or no improvement with clozapine or risperidone.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 10 and week 18 for reporting.

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

Awards & Highlights

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.

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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

clozapine

2006

N/A

~20

0 / 4Eligibility criteria met