What side effects are associated with this type of intervention?

Common treatments for schizophrenia include first-generation antipsychotics (FGAs) and second-generation antipsychotics (SGAs). FGAs, such as haloperidol and chlorpromazine, often cause extrapyramidal side effects (e.g., tremors, rigidity), tardive dyskinesia, and sedation. SGAs, like risperidone, olanzapine, and quetiapine, are associated with metabolic side effects (e.g., weight gain, diabetes), sedation, and, less frequently, extrapyramidal symptoms. Treatments targeting NMDA receptor function, such as those enhancing D-serine levels, may have different side effect profiles, but specific data on Luvadaxistat is limited. Generally, enhancing NMDA receptor function can potentially lead to cognitive improvements but may also carry risks of excitotoxicity and neuropsychiatric symptoms.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of schizophrenia, primarily focusing on antipsychotics. These include first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation antipsychotics such as risperidone, olanzapine, quetiapine, and aripiprazole. While these drugs primarily target dopamine receptors to manage psychotic symptoms, there has been interest in enhancing NMDA receptor function to improve cognitive deficits associated with schizophrenia. Memantine, an NMDA receptor antagonist, has been explored for cognitive enhancement, though it is primarily used for Alzheimer's disease. Luvadaxistat, a D-amino acid oxidase inhibitor that increases D-serine levels to enhance NMDA receptor function, represents a novel approach in this area.

What other types of research exist?

Promising alternatives to Luvadaxistat for schizophrenia patients in 2024 include: 1) Transcranial Magnetic Stimulation (TMS) - shown to have potential benefits in cognitive improvement. 2) Brexpiprazole - an antipsychotic with some evidence of cognitive benefits. 3) Cognitive Remediation Therapy (CRT) - a non-pharmacological approach that has shown efficacy in improving cognitive functions in schizophrenia. 4) Other NMDA receptor modulators under investigation, such as glycine and D-cycloserine, which aim to enhance NMDA receptor function similarly to Luvadaxistat.

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Luvadaxistat for Schizophrenia (ERUDITE Trial)

Verified Trial

Phase 2

Waitlist Available

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

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

Must have

Participant must be 18 to 50 years of age (inclusive) and able to comply with all protocol procedures.

Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, day 98

Awards & highlights

Summary

This trial is testing a daily pill called luvadaxistat to see if it can help people with schizophrenia think and remember better. Researchers want to find out if luvadaxistat is safe and effective for improving cognitive problems in these patients.

Who is the study for?

This trial is for adults aged 18-50 with schizophrenia diagnosed at least a year ago, stable symptoms for 3+ months, and on steady psychotropic meds. They need an adult informant, weigh at least 45 kg with a BMI of 18-45. Excluded are pregnant individuals, those with recent substance abuse or severe mental health risks.

What is being tested?

The study tests Luvadaxistat's ability to improve cognitive performance in schizophrenia patients against a placebo. Participants will be randomly assigned to receive either the drug or placebo while their cognitive changes are monitored.

What are the potential side effects?

While specific side effects aren't listed here, typically such trials monitor for any adverse reactions ranging from mild (headaches, nausea) to severe (allergic reactions). The safety profile of Luvadaxistat will be closely observed.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 50 years old and can follow all study procedures.

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I have been diagnosed with schizophrenia.

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I was diagnosed with schizophrenia over a year ago.

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I am on a stable dose of medication for my mental health.

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My symptoms have been stable for at least 3 months.

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I weigh at least 45 kg and my BMI is between 18.0 and 45.0.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, day 98

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, day 98

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 98 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Schizophrenia

Secondary study objectives

Change From Baseline on the Clinical Global Impression-Severity Scale (CGI-S) Score

Schizophrenia

Change From Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Luvadaxistat treatment schedule 2Experimental Treatment1 Intervention

Luvadaxistat daily

Group II: Luvadaxistat treatment schedule 1Experimental Treatment1 Intervention

Luvadaxistat daily

Group III: PlaceboPlacebo Group1 Intervention

Placebo daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Luvadaxistat

2018

Completed Phase 2

~290

0 / 7Eligibility 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 antipsychotic medications, which are categorized into first-generation (typical) and second-generation (atypical) antipsychotics. These drugs mainly target dopamine D2 receptors to reduce psychotic symptoms by decreasing dopamine activity. However, cognitive deficits in schizophrenia are not fully addressed by these treatments. Luvadaxistat, a D-amino acid oxidase inhibitor, aims to enhance NMDA receptor function by increasing D-serine levels, a co-agonist of the NMDA receptor. This approach is significant as it targets glutamatergic dysfunction, which is believed to contribute to cognitive impairments in schizophrenia, offering a potential avenue for improving cognitive outcomes in patients.

Glutamatergic drugs for schizophrenia.