What side effects are associated with this type of intervention?

Second-generation antipsychotics, commonly used to treat schizophrenia, modulate dopamine and serotonin pathways and are associated with several side effects. Aripiprazole and risperidone can cause metabolic issues such as weight gain, diabetes, and dyslipidemia. Olanzapine is known for significant weight gain and sedation. Quetiapine may cause sedation and orthostatic hypotension. Clozapine, although highly effective, carries risks of agranulocytosis, seizures, and myocarditis, necessitating regular blood monitoring. All these medications can also cause extrapyramidal symptoms, though to a lesser extent than first-generation antipsychotics.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, focusing on those that modulate dopamine and serotonin pathways. First-generation antipsychotics like haloperidol and chlorpromazine primarily target dopamine receptors. Second-generation antipsychotics, which include drugs like risperidone, olanzapine, quetiapine, and aripiprazole, target both dopamine and serotonin receptors, offering a broader mechanism of action. Aripiprazole, in particular, has been extensively studied and is known for its unique pharmacodynamic properties, making it a common choice for augmenting treatment in resistant cases.

What other types of research exist?

Several novel alternatives to traditional antipsychotic medications for schizophrenia are currently being explored. These include: 1) Lumateperone, which has shown promise in preventing relapse in schizophrenia patients and operates through a unique mechanism involving dopamine, serotonin, and glutamate pathways. 2) Brexpiprazole, which is a newer antipsychotic with a favorable side effect profile and is being studied for its efficacy and safety. 3) Other compounds in early development that target different neurotransmitter systems or novel pathways, though specific names and details are not provided in the context. These alternatives offer potential benefits in terms of efficacy and reduced side effects compared to traditional antipsychotics.

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Atypical Antipsychotic

Lumateperone for Schizophrenia

Q: What is the mechanism of action of this treatment?

The most common treatments for schizophrenia, particularly second-generation antipsychotics, work by modulating dopamine and serotonin pathways in the brain. These medications typically act as antagonists at dopamine D2 receptors and serotonin 5-HT2A receptors. By blocking dopamine receptors, they help reduce the positive symptoms of schizophrenia, such as hallucinations and delusions, which are thought to be linked to overactive dopamine signaling. The serotonin receptor antagonism helps mitigate some of the side effects associated with dopamine blockade and may also improve negative symptoms and cognitive deficits. This dual action is crucial for patients as it not only addresses the core symptoms of schizophrenia but also enhances overall treatment tolerability and effectiveness.

Phase 3

Waitlist Available

Research Sponsored by Intra-Cellular Therapies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5)

Current psychotic episode < 4 weeks duration at Visit 1

Must not have

Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial tests lumateperone, a medication for adults with schizophrenia. It aims to see if the drug can balance brain chemicals to improve symptoms like hallucinations and disorganized thinking. Lumateperone is approved for treating schizophrenia and depressive episodes related to bipolar depression in adults.

Who is the study for?

Adults aged 18-60 with schizophrenia for at least a year, experiencing moderate symptoms like delusions or hallucinations. They must have a caregiver and be at risk of suicide. Excluded are those with other mental disorders, recent substance abuse, treatment-resistant schizophrenia, or in their first psychosis episode.

What is being tested?

The study is testing Lumateperone (42 mg) against a placebo to prevent relapse in schizophrenia patients. It's conducted across multiple centers where participants are randomly assigned to either the drug or placebo group without knowing which one they receive.

What are the potential side effects?

While specific side effects for Lumateperone aren't listed here, antipsychotic medications can commonly cause drowsiness, weight gain, dry mouth, restlessness and sometimes more serious conditions like movement disorders or metabolic changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia based on DSM-5 criteria.

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My current psychotic episode has lasted less than 4 weeks.

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I have moderate symptoms of delusions, hallucinations, disorganization, or suspicion.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My schizophrenia hasn't improved after trying at least 2 different medications for over 6 weeks each.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lumateperone 42 mgExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumateperone 42 mg

2021

Completed Phase 1

~30

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for schizophrenia, particularly second-generation antipsychotics, work by modulating dopamine and serotonin pathways in the brain. These medications typically act as antagonists at dopamine D2 receptors and serotonin 5-HT2A receptors. By blocking dopamine receptors, they help reduce the positive symptoms of schizophrenia, such as hallucinations and delusions, which are thought to be linked to overactive dopamine signaling. The serotonin receptor antagonism helps mitigate some of the side effects associated with dopamine blockade and may also improve negative symptoms and cognitive deficits. This dual action is crucial for patients as it not only addresses the core symptoms of schizophrenia but also enhances overall treatment tolerability and effectiveness.

Dopamine Targeting Drugs for the Treatment of Schizophrenia: Past, Present and Future.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.Targeting the dopamine receptor in schizophrenia: investigational drugs in Phase III trials.