What is the mechanism of action of this treatment?

Common treatments for schizophrenia primarily involve antipsychotic medications, which work by modulating neurotransmitter activity in the brain. Risperidone, a second-generation antipsychotic, functions by blocking dopamine D2 receptors and serotonin 5-HT2A receptors, which helps reduce symptoms such as hallucinations, delusions, and thought disorders. This dual action is crucial as it addresses both positive and negative symptoms of schizophrenia. Long-acting formulations like LYN-005 are particularly beneficial as they ensure sustained medication release, improving adherence and reducing the risk of relapse, which is vital for the long-term management of schizophrenia.

What side effects are associated with this type of intervention?

Common treatments for schizophrenia, such as risperidone and other second-generation antipsychotics, often have side effects including weight gain, metabolic changes (e.g., increased blood sugar and cholesterol levels), and extrapyramidal symptoms (e.g., tremors, rigidity). Other side effects can include sedation, dizziness, and gastrointestinal issues. Long-acting formulations like LYN-005 aim to improve adherence but may still present similar side effects, with the added benefit of potentially reducing the frequency of dosing-related adverse effects.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both typical and atypical antipsychotics. Risperidone, an atypical antipsychotic, is commonly used and has been approved in various formulations, including long-acting injectable forms such as Risperdal Consta. Other long-acting injectable antipsychotics include aripiprazole (Abilify Maintena) and paliperidone palmitate (Invega Sustenna). These formulations are designed to improve adherence by providing sustained release of the medication, similar to the long-acting oral formulation of risperidone (LYN-005) being studied.

What other types of research exist?

Promising novel alternatives to LYN-005 for schizophrenia treatment in 2024 include: 1) Long-acting injectable formulations such as aripiprazole lauroxil and paliperidone palmitate, which offer sustained release and improved adherence. 2) Brexpiprazole and cariprazine, which are newer antipsychotics with favorable efficacy and tolerability profiles. 3) Investigational drugs like SEP-363856, which has shown promise in clinical trials for its novel mechanism of action targeting TAAR1 receptors.

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Long-Acting Oral Capsule

Long-Acting Oral LYN-005 for Schizophrenia

Phase 3

Waitlist Available

Led By Richard Scranton, MD, MPH

Research Sponsored by Lyndra Inc.

Eligibility Criteria Checklist

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

Must have

Male or female aged ≥18 and ≤64 years

Current diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria as confirmed by the Mini International Neuropsychiatric Interview for Psychotic Disorder Studies (MINI) version 7.0.2

Must not have

Participants with known clinically significant esophageal or gastrointestinal (GI) disease

Diagnosis of a condition known to elevate or lower gastric pH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to week 5

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new pill that releases risperidone slowly over time. It aims to help patients who need consistent medication levels, such as those with schizophrenia or bipolar disorder. The pill works by gradually releasing the medication, so patients don't have to take it as often. Risperidone has been used in various forms to treat schizophrenia and bipolar disorder, improving medication adherence and treatment effectiveness.

Who is the study for?

Adults aged 18-64 with a stable diagnosis of schizophrenia or schizoaffective disorder for at least 2 years, currently on oral antipsychotic medication, and in good physical health can join. They must not have gastrointestinal issues, major heart problems within the last 6 months, recent medical procedures, or be using certain medications that affect stomach acid or risperidone absorption.

What is being tested?

The trial is testing LYN-005, a long-acting oral capsule form of risperidone designed to release medication over time. Participants will receive multiple doses at two different strengths to assess how the body processes it and its safety.

What are the potential side effects?

Potential side effects may include those commonly associated with risperidone such as weight gain, fatigue, restlessness, constipation or diarrhea. Since this is an extended-release formulation there might also be unique side effects related to the long-term presence of the drug in the system.

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 64 years old.

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I have been diagnosed with schizophrenia or schizoaffective disorder.

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I have been on a stable dose of my non-antipsychotic medications for at least a month.

Exclusion Criteria

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

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I have a significant esophageal or gastrointestinal condition.

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I have a condition that affects my stomach acid levels.

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I have had varices or blockages in my intestines before.

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I have had surgery in my abdomen or upper digestive system.

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I have had swallowing problems or choking incidents in the past 5 years.

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I have a history of esophageal or gastric motility issues.

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I have had serious issues with diarrhea or constipation in the last 3 months.

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I have had several episodes of stomach pain in the last 3 months.

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I have moderate to severe acid reflux.

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I have a serious health condition that is not under control.

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I have a weakened immune system.

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I have not donated more than 250 mL of blood in the last 30 days.

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I have a history of seizures that are not caused by fever.

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I have had neuroleptic malignant syndrome in the past.

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I have or had significant involuntary movements.

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I am currently taking medication for stomach acid.

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I have used depot antipsychotics within the last 9 months.

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I have moderate to severe kidney problems.

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I have experienced significant drops in blood pressure upon standing.

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My genetic test shows I process some medications slowly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to week 5

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

Treatment Details

Study Objectives

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

Secondary study objectives

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) to Week 5

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: LYN-005 Containing 45-mg RisperidoneExperimental Treatment2 Interventions

During the run-in period (Day -7 to Day -1), participants receive Risperdal® (IR risperidone) daily. During the treatment period participants receive 5 weekly doses of LYN-005 45 mg (Days 1, 8, 15, 22, and 29) and Risperdal 3 mg from Day 1 to Day 7.

Group II: LYN-005 Containing 15-mg RisperidoneExperimental Treatment2 Interventions

During the run-in period (Day -7 to Day -1), participants receive Risperdal® (IR risperidone) daily. During the treatment period, participants receive 5 weekly doses of LYN-005 15 mg (Days 1, 8, 15, 22, and 29) and Risperdal 1 mg from Day 1 to Day 7.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LYN-005

2023

Completed Phase 3

~120

Risperidone

2011

Completed Phase 4

~3550

0 / 23Eligibility 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 work by modulating neurotransmitter activity in the brain. Risperidone, a second-generation antipsychotic, functions by blocking dopamine D2 receptors and serotonin 5-HT2A receptors, which helps reduce symptoms such as hallucinations, delusions, and thought disorders. This dual action is crucial as it addresses both positive and negative symptoms of schizophrenia. Long-acting formulations like LYN-005 are particularly beneficial as they ensure sustained medication release, improving adherence and reducing the risk of relapse, which is vital for the long-term management of schizophrenia.

Patterns of Management of Patients With Dual Disorder (Psychosis) in Italy: A Survey of Psychiatrists and Other Physicians Focusing on Clinical Practice.