What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotics such as clozapine, risperidone, olanzapine, and quetiapine. Known side effects of these medications can include metabolic syndrome, weight gain, sedation, extrapyramidal symptoms (e.g., akathisia, dystonia, parkinsonism), tardive dyskinesia, and neuroleptic malignant syndrome. Clozapine, while effective, requires careful monitoring due to risks like agranulocytosis. Second-generation antipsychotics are generally preferred due to a lower incidence of extrapyramidal symptoms compared to first-generation antipsychotics.

What prior FDA approvals exist?

The FDA has approved several second-generation antipsychotics for the treatment of schizophrenia, focusing on their safety, tolerability, and pharmacokinetics. These include aripiprazole, risperidone, olanzapine, and quetiapine, which are preferred due to their relatively favorable side effect profiles compared to first-generation antipsychotics. Clozapine is also approved but is reserved for treatment-resistant cases due to its significant side effects and the need for careful monitoring. These medications aim to reduce psychotic symptoms while minimizing adverse effects such as extrapyramidal symptoms and metabolic syndrome.

What other types of research exist?

Promising novel alternatives to MK-5720 for schizophrenia treatment include MK-8189, which has shown safety and tolerability in multiple once-daily oral doses. Additionally, switching from antipsychotic polypharmacy to monotherapy using the SCAP method has been effective without deteriorating psychiatric symptoms. Other second-generation antipsychotics (SGAs) like paliperidone extended-release tablets have also demonstrated efficacy, safety, and acceptability in recent studies.

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MK-5720 + MK-8189 for Schizophrenia

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

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 up to approximately 12 months

Summary

This trial tests two new drugs, MK-5720 (a single muscle shot) and MK-8189 (a daily pill), in people with schizophrenia to see if they are safe and how the body handles them.

Who is the study for?

This trial is for individuals with schizophrenia or schizoaffective disorder, diagnosed at least 2 years ago. Participants must have a history of tolerating antipsychotic medications and can stop their current medication for the study duration. They cannot join if they have severe allergies, metal implants preventing MRI scans, certain infections like HIV or hepatitis, are at risk of self-harm, or have specific psychiatric exclusions.

What is being tested?

The study tests MK-5720 given as single intramuscular doses and MK-8189 taken orally once daily against placebos to assess safety and how the body processes these drugs in people with schizophrenia. The hypothesis suggests that MK-5720 will be safe and well-tolerated.

What are the potential side effects?

While not explicitly listed in the provided information, common side effects for antipsychotics may include drowsiness, weight gain, dry mouth, restlessness and sometimes more serious effects like movement disorders or metabolic changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

AUC0-inf of MK-8189

Apparent Clearance (CL/F) of MK-5720

Apparent Terminal Half-life (t1/2) of MK-5720

+16 more

Secondary study objectives

AUC0-28d of MK-8189 in Gluteal Muscle Versus AUC0-28 of MK-8189 in Deltoid Muscle

AUC0-inf of MK-5720 in Gluteal Muscle Versus AUC0-inf of MK-5720 in Deltoid Muscle

AUC0-inf of MK-8189 in Gluteal Muscle Versus AUC0-inf of MK-8189 in Deltoid Muscle

+13 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Panel FExperimental Treatment4 Interventions

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 6 or a dose matched placebo (Period 2).

Group II: Panel EExperimental Treatment4 Interventions

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 5 or a dose matched placebo (Period 2).

Group III: Panel DExperimental Treatment4 Interventions

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 4 or a dose matched placebo (Period 2).

Group IV: Panel CExperimental Treatment4 Interventions

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 3 or a dose matched placebo (Period 2).

Group V: Panel BExperimental Treatment4 Interventions

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single IM injection of MK-5720 at a specified Dose 2 or a dose matched placebo (Period 2).

Group VI: Panel AExperimental Treatment4 Interventions

Participants receive 7 days of oral MK-8189 or matched placebo treatment (Period 1), followed by a single intramuscular (IM) injection of MK-5720 at a specified Dose 1 or a dose matched placebo (Period 2).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo to MK-5720

2023

Completed Phase 1

~20

MK-8189

2020

Completed Phase 2

~1180

Placebo to MK-8189

2023

Completed Phase 2

~520

MK-5720

2023

Completed Phase 1

~20

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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 are antipsychotic medications, which primarily work by modulating neurotransmitter activity in the brain. Typical antipsychotics, like haloperidol, block dopamine D2 receptors, reducing dopamine activity that is often elevated in schizophrenia. Atypical antipsychotics, such as risperidone and aripiprazole, target both dopamine and serotonin receptors, offering a broader mechanism of action that can help alleviate both positive and negative symptoms of schizophrenia. These mechanisms are crucial as they address the underlying neurochemical imbalances, helping to manage symptoms and improve quality of life. The trial of MK-5720 focuses on evaluating the safety and pharmacokinetics of new treatments, which could offer additional therapeutic options with potentially better tolerability and efficacy.

New Pharmacological Targets for the Treatment of Schizophrenia: A Literature Review.Polypharmacy with second-generation antipsychotics: a review of evidence.Treatments for schizophrenia: a critical review of pharmacology and mechanisms of action of antipsychotic drugs.