What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics like aripiprazole, risperidone, quetiapine, and olanzapine, share side effects such as weight gain, metabolic syndrome, extrapyramidal symptoms, sedation, and increased prolactin levels. Cardiovascular side effects like orthostatic hypotension and QT prolongation are also noted.

What prior FDA approvals exist?

The FDA has approved several second-generation antipsychotics for the treatment of schizophrenia, which function similarly to Brilaroxazine by modulating serotonin and dopamine receptors. These include aripiprazole, risperidone, quetiapine, olanzapine, and ziprasidone. These medications are known for their efficacy in managing both positive and negative symptoms of schizophrenia while generally having a more favorable side effect profile compared to first-generation antipsychotics.

What other types of research exist?

Promising novel alternatives to Brilaroxazine for schizophrenia treatment in 2024 include: 1. Lumateperone (Caplyta) - A novel antipsychotic with a unique mechanism of action, showing efficacy and a favorable safety profile. 2. KarXT (Xanomeline-Trospium) - A muscarinic receptor agonist combination showing promise in clinical trials for reducing both positive and negative symptoms of schizophrenia. 3. SEP-363856 - A novel antipsychotic that does not primarily target dopamine receptors, showing efficacy in clinical trials with a potentially better side effect profile.

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Serotonin-Dopamine Activity Modulator

Brilaroxazine for Schizophrenia (RECOVER Trial)

Phase 3

Recruiting

Research Sponsored by Reviva Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests Brilaroxazine, a daily pill, in patients with severe mental health issues. It aims to improve mood and reduce symptoms. The study lasts for more than a year.

Who is the study for?

Adults aged 18-65 with acute schizophrenia can join this trial. They must understand and sign a consent form, have not used certain antipsychotics recently or drugs that strongly affect the body's enzyme systems, and cannot have treatment-resistant schizophrenia, history of clozapine use, substance abuse disorders within the last six months, brain injuries affecting cognition, dementia or other CNS diseases.

What is being tested?

The study tests Brilaroxazine's safety and effectiveness against a placebo in treating acute schizophrenia. Participants will receive either 15 mg or 50 mg daily for one month followed by flexible dosing up to 52 weeks to see how well it works short-term and long-term.

What are the potential side effects?

Possible side effects of Brilaroxazine may include typical antipsychotic drug reactions such as drowsiness, restlessness (akathisia), weight gain, dry mouth, constipation, blurred vision or dizziness. Long-term effects are being studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 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

Double Blind Safety and Efficacy of Brilaroxazine (RP5063)

Open label Safety and Efficacy of Brilaroxazine (RP5063)

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: RP5063 15 mg once dailyActive Control1 Intervention

administered OD for 28 days then flexibly 15-50mg over a period of 52 weeks.

Group II: RP5063 (brilaroxazine) 50 mg once dailyActive Control1 Intervention

administered OD for 28 days, then flexibly 15-50mg over a period of 52 weeks

Group III: PlaceboPlacebo Group1 Intervention

administered OD for 28 days.

Do I qualify?Apply below to find out

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 include antipsychotic medications, which primarily function by modulating neurotransmitter activity in the brain. First-generation antipsychotics (FGAs) mainly block dopamine D2 receptors, reducing dopamine activity to alleviate psychotic symptoms. Second-generation antipsychotics (SGAs) or atypical antipsychotics, such as risperidone, quetiapine, and olanzapine, not only block dopamine D2 receptors but also affect serotonin receptors, particularly 5-HT2A receptors. This dual action helps in managing both positive symptoms (like hallucinations and delusions) and negative symptoms (such as social withdrawal and apathy) of schizophrenia. Brilaroxazine, a serotonin-dopamine modulator, aims to balance serotonin and dopamine activity more precisely, potentially offering improved efficacy and reduced side effects. Understanding these mechanisms is crucial for schizophrenia patients as it informs the choice of medication that can best manage their symptoms with the least adverse effects.