What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly antipsychotics that modulate neurotransmitter systems, often have a range of side effects. First-generation antipsychotics, like haloperidol, frequently cause extrapyramidal symptoms (EPS) such as akathisia, dystonia, and parkinsonism. Second-generation antipsychotics, such as risperidone and aripiprazole, tend to have fewer EPS but can still cause metabolic side effects like weight gain, diabetes, and dyslipidemia. Other side effects across these medications can include sedation, anticholinergic effects (dry mouth, constipation), and, less commonly, cardiovascular issues. Clozapine, although highly effective, is associated with significant risks like agranulocytosis and requires regular blood monitoring.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of schizophrenia, primarily focusing on the modulation of neurotransmitter systems. First-generation antipsychotics, such as haloperidol and chlorpromazine, primarily target dopamine receptors. Second-generation antipsychotics, including risperidone, olanzapine, and aripiprazole, target both dopamine and serotonin receptors, offering a broader mechanism of action and improved side effect profiles. More recently, drugs like brexpiprazole and cariprazine have been approved, which also modulate dopamine and serotonin receptors but with different receptor binding profiles. These treatments aim to address the complex neurotransmitter imbalances associated with schizophrenia.

What other types of research exist?

Promising novel alternatives to Emraclidine for schizophrenia treatment in 2024 include second-generation antipsychotics such as risperidone, olanzapine, and aripiprazole, which have favorable efficacy and side effect profiles. Additionally, ongoing research into other novel agents like VMAT2 inhibitors (e.g., deutetrabenazine) and potential new antipsychotics targeting different neurotransmitter systems may offer new options.

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NMDA receptor antagonist

Emraclidine for Schizophrenia

Verified Trial

Phase 2

Recruiting

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

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

Must have

Are you currently taking Antipsychotic medication?

Be older than 18 years old

Must not have

Are currently taking 3 or more medications to control your blood pressure

Have you been diagnosed with Major Depressive Disorder or PTSD or Obsessive-Compulsive Disorder?

Timeline

Screening 15 days

Treatment 56 weeks

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to evaluate the safety and tolerability of a medication called emraclidine, taken by mouth, in adults with schizophrenia.

Who is the study for?

This trial is for adults aged 18-65 with schizophrenia who can understand the study and follow its procedures. It's not for those whose only response to treatment has been clozapine, or have progressive brain diseases, severe head trauma history, seizures (except childhood febrile seizures), or a high risk of suicide.

What is being tested?

The study is testing the long-term safety and how well people can tolerate CVL-231 (Emraclidine) at a dose of 30 mg. Emraclidine is taken orally by participants with schizophrenia to evaluate its effects over an extended period.

What are the potential side effects?

While specific side effects are not listed here, this trial aims to monitor any adverse reactions from taking oral emraclidine in patients with schizophrenia over time.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Select...

I am on three or more medications for my blood pressure.

Timeline

Screening ~ 15 days1 visit

Treatment ~ 56 weeks10 visits

Follow Up ~ 4 weeks-1 visits

Screening ~ 15 days

Treatment ~ 56 weeks

Follow Up ~4 weeks

This trial's timeline: 15 days for screening, 56 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score

Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score

Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CVL-231 30 mgExperimental Treatment1 Intervention

Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.

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

Common treatments for schizophrenia primarily involve the modulation of neurotransmitter systems, particularly dopamine and serotonin receptors. First-generation antipsychotics typically block dopamine D2 receptors, which helps reduce psychotic symptoms but can cause side effects like parkinsonism. Second-generation antipsychotics also target serotonin receptors, which can improve efficacy and reduce some side effects. Newer treatments, such as Emraclidine, aim to modulate other neurotransmitter systems and receptors implicated in schizophrenia, potentially offering better symptom control and fewer side effects. Understanding these mechanisms is crucial for optimizing treatment, improving patient outcomes, and minimizing adverse effects.

Tricyclic antipsychotics and antidepressants can inhibit α5-containing GABAA receptors by two distinct mechanisms.Potential Utility of Biased GPCR Signaling for Treatment of Psychiatric Disorders.