What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics like aripiprazole, risperidone, and clozapine, are associated with a range of side effects. These can include metabolic syndrome, weight gain, diabetes, and cardiovascular risks. Extrapyramidal symptoms (EPS) such as akathisia, dystonia, and parkinsonism are less common with second-generation antipsychotics compared to first-generation ones. Clozapine, while effective, carries risks of agranulocytosis, requiring regular blood monitoring. Other side effects may include sedation, increased risk of stroke, and neuropsychiatric symptoms like anxiety and agitation.

What prior FDA approvals exist?

The FDA has approved several second-generation antipsychotics for the treatment of schizophrenia, including aripiprazole, quetiapine, risperidone, and ziprasidone. These medications are often preferred due to their efficacy and relatively favorable side effect profiles compared to first-generation antipsychotics. Aripiprazole, for example, is frequently used because it tends to cause fewer side effects. Other notable approvals include brexpiprazole and cariprazine, which are also used as adjunctive treatments for resistant depression, indicating their versatility in managing psychiatric conditions.

What other types of research exist?

Promising novel alternatives for schizophrenia treatment in 2024 include: 1) Pimavanserin, a serotonin-receptor modulator (5HT2A inverse agonist and antagonist) with no dopamine D2 affinity, which has shown efficacy in dementia-related psychosis and may be beneficial for schizophrenia. 2) mGlu2/3 receptor agonists, despite mixed results, continue to be explored for their potential in treating psychosis. 3) Clozapine, although not new, remains a gold standard for treatment-resistant schizophrenia and is continually being studied for optimization and safety improvements.

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Unknown

NBI-1117568 for Schizophrenia

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and week 6

Summary

This trial is testing a new medication called NBI-1117568 to see if it can help adults with schizophrenia who are experiencing a worsening of their symptoms. The study will check how well the medication works, how safe it is, and how well patients can tolerate it. The goal is to find an effective treatment for those whose condition is getting worse.

Who is the study for?

Adults with schizophrenia who are currently experiencing a worsening of symptoms and need hospitalization can join. They must stop taking any disallowed medications, agree to stay in the hospital for the study, and follow all instructions. People using certain substances or with unstable health conditions, a risk of self-harm, or recent substance abuse issues cannot participate.

What is being tested?

The trial is testing NBI-1117568's effectiveness and safety against a placebo in adults with schizophrenia during an acute episode. It's well-controlled: participants don't know if they're getting the real drug or placebo, nor do the researchers (double-blind).

What are the potential side effects?

While specific side effects aren't listed here, typically antipsychotic drugs may cause drowsiness, restlessness, weight gain, dry mouth, blurred vision and constipation. The trial will monitor for these common reactions as well as any unique to NBI-1117568.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6 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 from baseline in total Positive and Negative Syndrome Scale (PANSS) score at Week 6

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose Level DExperimental Treatment1 Intervention

Participant administered Dose Level D (6 weeks)

Group II: Dose Level CExperimental Treatment1 Intervention

Participant administered Dose Level C (6 weeks)

Group III: Dose Level BExperimental Treatment1 Intervention

Participant administered Dose Level B (6 weeks)

Group IV: Dose Level AExperimental Treatment1 Intervention

Participant administered Dose Level A (6 weeks)

Group V: Placebo SchedulePlacebo Group1 Intervention

Participant administered placebo (6 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBI-1117568

2022

Completed Phase 2

~210

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

Common treatments for schizophrenia primarily involve antipsychotic medications that target neurotransmitter systems in the brain. Typical antipsychotics mainly block dopamine D2 receptors, which helps reduce positive symptoms like hallucinations and delusions. Atypical antipsychotics also affect serotonin receptors, which can improve both positive and negative symptoms, such as social withdrawal and lack of motivation. Novel treatments, like those being studied in trials such as NBI-1117568, may offer new mechanisms of action that could provide better efficacy or fewer side effects. Understanding these mechanisms helps patients and doctors make informed decisions about the most appropriate and effective treatment options.

Potential Utility of Biased GPCR Signaling for Treatment of Psychiatric Disorders.The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].