Clozapine

Schizophrenia, Advance Directives, Parkinson Disease + 6 more

Treatment

10 FDA approvals

20 Active Studies for Clozapine

What is Clozapine

Clozapine

The Generic name of this drug

Treatment Summary

Clozapine is a type of antipsychotic medication that works by blocking serotonin and dopamine receptors in the brain. It is an atypical drug, meaning it works differently from other antipsychotic medications. Although it is effective in treating psychotic disorders, the main side effect is a serious decrease in white blood cells, which can lead to infection.

Clozaril

is the brand name

image of different drug pills on a surface

Clozapine Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Clozaril

Clozapine

1989

97

Approved as Treatment by the FDA

Clozapine, also called Clozaril, is approved by the FDA for 10 uses which include Schizophrenia, Treatment-Resistant and Schizoaffective Disorders .

Schizophrenia, Treatment-Resistant

Helps manage Treatment Resistant Schizophrenia

Schizoaffective Disorders

Helps manage Schizoaffective Disorders

Suicidal Behaviour

Helps manage Suicidal Behaviour

Treatment Resistant Schizophrenia

Helps manage Treatment Resistant Schizophrenia

Severe Mental Illness

Helps manage Severe Mental Illness

Disease

Helps manage inadequate response to conventional therapy

Schizoaffective Disorder

Helps manage Schizoaffective Disorders

Schizophrenia

Helps manage Schizophrenia

High Risk

Helps manage High Risk

Suicide

Helps manage Suicidal Behaviour

Effectiveness

How Clozapine Affects Patients

Clozapine is a medication used to treat schizophrenia. It works by blocking certain receptors in the brain and has effects on serotonin, dopamine, adrenaline, and histamine. Common side effects include dry mouth, dizziness, and drowsiness. Clozapine can also cause serious side effects such as agranulocytosis (low white blood cell count) and myocarditis (inflammation of the heart). Patients taking clozapine should be monitored closely for these conditions, and if they occur, clozapine should not be re-taken.

How Clozapine works in the body

Clozapine combats the symptoms of psychosis by blocking certain chemical receptors in the brain. In the mesolimbic pathway, the drug blocks D2 receptors to reduce positive symptoms, and in the frontal cortex, it blocks 5-HT2A receptors to reduce negative symptoms.

When to interrupt dosage

The proposed measure of Clozapine is contingent upon the diagnosed condition, including High Risk, Severe Mental Illness and Schizoaffective Disorder. The dosage also varies as per the mode of administration listed in the table beneath.

Condition

Dosage

Administration

Severe Mental Illness

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Parkinson Disease

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Schizophrenia

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Advance Directives

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Schizoaffective Disorder

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

High Risk

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Suicide

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Disease

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Schizophrenia, Treatment-Resistant

, 25.0 mg, 100.0 mg, 50.0 mg, 200.0 mg, 12.5 mg, 150.0 mg, 50.0 mg/mL

Oral, Tablet, , Tablet - Oral, Suspension, Suspension - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral

Warnings

There are 20 known major drug interactions with Clozapine.

Common Clozapine Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Clozapine.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Clozapine.

Acepromazine

Major

Clozapine may increase the orthostatic hypotensive, hypotensive, and antihypertensive activities of Acepromazine.

Aclidinium

Major

The risk or severity of adverse effects can be increased when Clozapine is combined with Aclidinium.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Clozapine.

Clozapine Toxicity & Overdose Risk

Clozapine carries a serious warning for a condition called agranulocytosis, which can lead to decreased white blood cell counts.

image of a doctor in a lab doing drug, clinical research

Clozapine Novel Uses: Which Conditions Have a Clinical Trial Featuring Clozapine?

230 ongoing investigations are assessing the utility of Clozapine in treating High Risk Patients, Parkinsonian Syndromes and Suicidal Ideation.

Condition

Clinical Trials

Trial Phases

Schizophrenia

97 Actively Recruiting

Phase 3, Not Applicable, Early Phase 1, Phase 4, Phase 1, Phase 2

Schizoaffective Disorder

43 Actively Recruiting

Phase 4, Phase 1, Phase 2, Not Applicable, Phase 3

Schizophrenia, Treatment-Resistant

4 Actively Recruiting

Not Applicable, Phase 4, Phase 3

Suicide

5 Actively Recruiting

Not Applicable

Advance Directives

0 Actively Recruiting

High Risk

0 Actively Recruiting

Disease

0 Actively Recruiting

Parkinson Disease

0 Actively Recruiting

Severe Mental Illness

0 Actively Recruiting

Clozapine Reviews: What are patients saying about Clozapine?

4.7

Patient Review

1/17/2022

Clozapine for Schizophrenia

I was on clozapine for more than two years and it made a big difference for me. I recommend getting started with this treatment at a hospital so they can do all the necessary tests and monitor you closely. The side effects can be serious, so it's important to start with a low dose and increase gradually if needed.

4.7

Patient Review

3/14/2014

Clozapine for Schizophrenia

I've tried a lot of different medications for my schizophrenia, and this one is by far the best. It's stopped hallucinations, delusions, everything. The only downside is that it makes me very sleepy; I go from about 8 hours of sleep per night to 12. But even that is worth it given how well this medicine works.

4.7

Patient Review

12/29/2011

Clozapine for Suicidal Behavior in Schizoaffective Disorder

Worked for me quickly and effectively. I had to be hospitalized when they first started the treatment due to hallucinations, but these stopped after a short while and I haven't experienced any negative side effects in the six years since.

4.7

Patient Review

5/9/2014

Clozapine for Suicidal Behavior in Schizoaffective Disorder

This medication has been pivotal in saving my life. It requires dedication and compliance, but it's worth it. I've been taking it for 18 years now.

3.3

Patient Review

4/3/2014

Clozapine for Mania associated with Bipolar Disorder

I'm on this medication for bipolar disorder and it's been working pretty well so far. The only downside is that I have to get blood tests every week to make sure my white blood cell levels are still good. CVS pharmacy won't release the medication to me unless they also get a copy of my weekly blood test results.

2

Patient Review

11/9/2014

Clozapine for Schizophrenia

While clozapine may be effective for some, I would urge caution. It is a very powerful drug with many potential side effects. There is also the risk of major relapse if you try to stop taking it, so make sure you are fully informed before making a decision.

1.7

Patient Review

3/23/2022

Clozapine for Suicidal Behavior in Schizophrenia

I had a very severe allergic reaction to this treatment that led to anaphylactic shock and death. I was resuscitated and had to be monitored constantly for six weeks afterwards because I couldn't move or eat on my own.

1

Patient Review

4/2/2022

Clozapine for Schizophrenia

I don't recommend this medication because it made me depressed and caused me to have no interest in the things I used to enjoy. It also made me tired and more likely to drink alcohol, which is dangerous given the interactions between the two substances.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about clozapine

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the drug clozapine used for?

"This medication is prescribed to patients with severe schizophrenia who have not responded well to other medications. It is also used to lower the risk of suicide in patients with schizophrenia or schizoaffective disorder."

Answered by AI

Why is clozapine high risk?

"Clozapine causes several severe side effects, including a decrease in white blood cells, a decrease in neutrophils (a type of white blood cell), constipation (which can be severe), inflammation of the heart muscle, and negative effects on metabolism. These side effects can occur at any time during treatment and are not necessarily linked to the dose of the drug."

Answered by AI

What class of drug is clozapine?

"This drug is classified as atypical because it affects both serotonin and dopamine receptors."

Answered by AI

What is the major side effect of clozapine?

"Taking clozapine may cause you to feel dizzy, lightheaded, or like you're going to faint when you stand up, especially when you first start taking it or when your dose is increased. If you've had a heart attack, heart failure, or a slow, irregular heartbeat in the past, or if you're taking medication for high blood pressure, tell your doctor."

Answered by AI

Clinical Trials for Clozapine

Image of Rutgers University Behavioral Healthcare in Piscataway, United States.

Sleepio for Suicidal Thoughts

14 - 18
All Sexes
Piscataway, NJ

The purpose of this research study is to compare (vs. treatment as usual) a brief (6-session), empirically supported, and highly disseminable version of digital (i.e., smartphone or web-based) cognitive behavioral therapy for insomnia (dCBT-I), called SleepioTM, in suicidal adolescents with co-occurring insomnia during the high-risk post-hospitalization period. Suicide is the 2nd leading cause of death among adolescents. Sleep problems, such as insomnia symptoms-the most common sleep problem in youth-may be a particularly promising treatment target to reduce suicide risk in adolescents. The investigators propose to test the feasibility, acceptability, and effectiveness of dCBT-I in a two-site (Rutgers and Old Dominion University) pilot study trial. Adolescents, 14-18 years-old, recently hospitalized for suicide risk with co-occurring insomnia (n=80, 50% at each site), will receive either dCBT-I (six weekly, 20-minute sessions) plus post-hospitalization treatment-as-usual (TAU) or TAU alone. Adolescents will complete assessments pre-treatment, during the treatment phase including at the end of treatment, and 1-month follow-up post-treatment.

Recruiting
Has No Placebo

Rutgers University Behavioral Healthcare (+1 Sites)

Evan Kleiman

Image of The University of Iowa in Iowa City, United States.

fMRI for Cognitive Flexibility

18 - 35
All Sexes
Iowa City, IA

The goal of this basic experimental research study is to examine how the human thalamus supports flexible thinking and behavior. Specifically, the research aims to elucidate how the mediodorsal (MD) thalamus encodes and updates "context"-the mental framework that determines which rules or actions are relevant in a given situation. This work may contribute to understanding why certain psychiatric conditions, such as schizophrenia and ADHD, involve difficulties with cognitive flexibility and control. The primary research questions are: Does the MD thalamus represent the context that organizes how working memory guides task selection? Does the MD thalamus signal when context needs to be updated after a change in task demands? Do these thalamic representations support generalization to new situations or rules? Participants will complete cognitive tasks while undergoing high-resolution brain imaging using 7-Tesla MRI. The investigators will combine behavioral data, computational modeling, and advanced neuroimaging analyses to examine how the thalamus interacts with the cortex during flexible decision-making.

Waitlist Available
Has No Placebo

The University of Iowa

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Repetitive Transcranial Magnetic Stimulation for Schizophrenia

18 - 65
All Sexes
Nashville, TN

The central hypothesis is this: DMN connectivity can be modulated with inhibitory cTBS when delivered on an accelerated treatment schedule. This study seeks to provide evidence that accelerated, network-targeted inhibitory stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cognitive performance in individuals with schizophrenia and schizoaffective disorder. This study will also compare the effect of inhibitory cTBS in healthy individuals, as it may also lead to both altered network activity and a behavioral change in cognitive performance in individuals without schizophrenia or schizoaffective disorder. If successful, this study will have identified a safe, effective, and broadly applicable treatment for cognitive impairment in schizophrenia that has potential for translation into many other psychiatric and neurodevelopmental disorders, such as autism.

Waitlist Available
Has No Placebo

Vanderbilt Psychiatric Hospital

Heather Ward, MD

Image of Woodland International Research Group /ID# 275747 in Little Rock, United States.

Emraclidine for Schizophrenia

18 - 65
All Sexes
Little Rock, AR

Schizophrenia is a common and severe psychiatric illness characterized by extreme disturbances of cognition and thought, affecting language, perception and sense of self. This study will assess adverse events, change in disease activity, and how oral emraclidine moves through the body in adult participants with schizophrenia Emraclidine is an investigational drug being developed for the treatment of schizophrenia. Participants are placed in one of two parts, Part A or Part B, where each group will receive a different treatment. Participants will receive either oral emraclidine or placebo. Approximately 258 participants will be enrolled across roughly 32 sites in the United States. Participants in Part A will be assigned to one of multiple ascending doses of emraclidine or placebo administered orally for 14 days or up to 21 days. Participants in Part B will receive Emraclidine or placebo administered orally for up to 42 days. Participants will be followed for 30 days after the last dose of the study drug. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Phase 2
Recruiting

Woodland International Research Group /ID# 275747 (+6 Sites)

ABBVIE INC.

AbbVie

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iTEST for Psychosis

18 - 65
All Sexes
San Diego, CA

The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or a control condition that receives coaching and cognitive training that does not emphasize introspective accuracy. Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks. The primary outcome of the study is community functioning. Participants will be from three metropolitan areas: San Diego, Dallas, or Miami.

Recruiting
Has No Placebo

UC San Diego (+2 Sites)

Amy Pinkham, PhD

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We made a collection of clinical trials featuring Clozapine, we think they might fit your search criteria.
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