What side effects are associated with this type of intervention?

Common treatments for schizophrenia include second-generation antipsychotics such as aripiprazole, risperidone, and clozapine. These medications are preferred due to their lower risk of extrapyramidal symptoms (EPS) compared to first-generation antipsychotics. However, they can still cause side effects such as weight gain, metabolic syndrome, sedation, and increased risk of diabetes. Valbenazine, a VMAT2 inhibitor, is used to manage tardive dyskinesia, a potential side effect of long-term antipsychotic use. Known side effects of Valbenazine include somnolence, fatigue, and anticholinergic effects such as dry mouth and constipation.

What prior FDA approvals exist?

Valbenazine is a VMAT2 (vesicular monoamine transporter 2) inhibitor, primarily used for the treatment of tardive dyskinesia, a condition often associated with long-term antipsychotic use in schizophrenia patients. Other FDA-approved treatments for schizophrenia include a range of antipsychotic medications, both first-generation (typical) and second-generation (atypical) antipsychotics. Examples of these include haloperidol, chlorpromazine, risperidone, olanzapine, and clozapine. While VMAT2 inhibitors like Valbenazine are not primarily approved for treating schizophrenia itself, they play a crucial role in managing side effects related to antipsychotic treatments.

What other types of research exist?

Promising novel alternatives to Valbenazine for Schizophrenia treatment include Brexpiprazole and Cariprazine. Both have shown efficacy and safety as adjunctive treatments in recent clinical trials.

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Valbenazine for Schizophrenia

Phase 3

Recruiting

Research Sponsored by Neurocrine Biosciences

Eligibility Criteria Checklist

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

Must have

Medically confirmed diagnosis of schizophrenia

Participant is receiving a stable regimen of background antipsychotic medication

Must not have

Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 10

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether adding the medication valbenazine can help people with schizophrenia who haven't improved enough with regular antipsychotic drugs. Valbenazine aims to balance brain chemicals to reduce symptoms.

Who is the study for?

This trial is for adults with schizophrenia who aren't responding well to their current antipsychotic medication. They must have a stable regimen of this medication, detectable plasma levels, and be outpatients with steady symptoms. An adult informant must be involved in their care. Those with treatment-resistant schizophrenia or unstable medical conditions are excluded.

What is being tested?

The study tests if Valbenazine added to existing antipsychotic treatment helps reduce schizophrenia symptoms better than a placebo (a substance with no active drug). Participants will randomly receive either Valbenazine or the placebo alongside their regular medication.

What are the potential side effects?

Valbenazine may cause side effects like sleepiness, balance problems, dry mouth, and restlessness. It might also lead to gastrointestinal issues such as nausea or constipation.

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 by a doctor.

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I am on a steady dose of medication for psychosis.

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My antipsychotic medication levels can be measured by a test.

Exclusion Criteria

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

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I have not used VMAT2 inhibitors in the last 6 months and have no intolerance to them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10

Secondary study objectives

Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10

Change in Personal and Social Performance (PSP) Score from Baseline to Week 10

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: ValbenazineExperimental Treatment1 Intervention

Valbenazine once daily

Group II: PlaceboPlacebo Group1 Intervention

Placebo once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Valbenazine

2018

Completed Phase 4

~880

0 / 4Eligibility 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 include second-generation antipsychotics and VMAT2 inhibitors. Second-generation antipsychotics work by blocking dopamine D2 receptors, which helps alleviate positive symptoms like hallucinations and delusions. VMAT2 inhibitors, such as valbenazine, reduce the release of dopamine and other monoamines by inhibiting the vesicular monoamine transporter 2. This mechanism can help manage symptoms and reduce side effects related to dopamine dysregulation. Understanding these mechanisms is important for tailoring treatment to individual symptom profiles and minimizing adverse effects.

Antipsychotic-induced tardive dyskinesia: update on epidemiology and management.Significant Effect of Valproate Augmentation Therapy in Patients With Schizophrenia: A Meta-analysis Study.Treatment of early onset schizophrenia: recent trends, challenges and future considerations.