MK-8189 for Schizophrenia

Recruiting at 127 trial locations

Overseen By Toll Free Number

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must not be taking: Clozapine

Disqualifiers: Substance use disorder, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently using clozapine or have a history of treatment resistance, you may not be eligible to participate.

What data supports the effectiveness of the drug MK-8189 for schizophrenia?

Risperidone, a component of the treatment, has been shown to be effective in treating schizophrenia, including in patients who are treatment-resistant. Studies have demonstrated its long-term benefits and lower relapse rates compared to conventional treatments. ^{1 2 3 4 5}

Is MK-8189 safe for humans?

Risperidone, which is related to MK-8189, has been used safely for many years to treat schizophrenia and other conditions. It is known for its balance of effectiveness and safety, with a well-understood side effect profile. ^{1 6 7 8 9}

How is the drug MK-8189 for schizophrenia different from other treatments?

MK-8189 is unique because it is being studied for its potential to improve cognitive function in schizophrenia, which is not a primary focus of many existing antipsychotics. Unlike other treatments, it may target specific brain receptors involved in learning and memory, potentially offering benefits for cognitive symptoms that are often challenging to treat. ^{10 11 12 13 14}

What is the purpose of this trial?

This trial tests the effectiveness and safety of a medication called MK-8189 in adults with acute schizophrenia. The study compares different doses of the medication to see if it can better reduce symptoms. The goal is to find out if MK-8189 can help improve the condition of these patients.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with an acute episode of schizophrenia, diagnosed per DSM-5 criteria. Participants must be moderately ill or worse and have had schizophrenia for at least a year. It excludes those with other psychotic disorders, certain personality disorders, brain injuries affecting cognition, Alzheimer's, other dementias, severe central nervous system diseases, or intellectual disabilities.

Inclusion Criteria

I have been diagnosed with schizophrenia for at least one year.

I have been diagnosed with schizophrenia.

You have a score of 4 or higher on the CGI-S scale, which means you are moderately ill.

Exclusion Criteria

You have a mental illness other than schizophrenia or behavioral problems caused by substance abuse.

I do not have a mental health condition or brain disorder that would affect my study participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Treatment

Participants receive MK-8189 or risperidone for 6 weeks to assess efficacy and safety

6 weeks

Weekly visits (in-person)

Extension Treatment

Participants continue receiving MK-8189 or risperidone for an additional 6 weeks

6 weeks

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MK-8189
• Placebo to MK-8189
• Placebo to risperidone
• Risperidone

Trial Overview The study tests the effectiveness and safety of MK-8189 in doses of 8 mg (limited to early enrollees), 16 mg, and 24 mg against placebos. The goal is to see if MK-8189 can better reduce symptoms measured by the PANSS score after six weeks compared to placebo.

Participant Groups

Group I: Placebo to MK-8189 (Acute) - MK-8189 24 mg (Extension) Experimental Treatment 3 Interventions

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189-matching placebo QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.

Group II: MK-8189 8 mg (Acute) - MK-8189 8 mg (Extension) Experimental Treatment 2 Interventions

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 8 mg once daily (QD) in the acute treatment period from Week 1-6 followed by MK-8189 8 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12. Enrollment of participants in the MK-8189 8 mg arm was closed with Amendment 4. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.

Group III: MK-8189 24 mg (Acute) - MK-8189 24 mg (Extension) Experimental Treatment 2 Interventions

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 24 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 24 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.

Group IV: MK-8189 16 mg (Acute) - MK-8189 16 mg (Extension) Experimental Treatment 2 Interventions

Participants will be treated for a total of 12 weeks. Participants will receive MK-8189 16 mg QD in the acute treatment period from Week 1-6 followed by MK-8189 16 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive risperidone-matching placebo QD from Week 1-12.

Group V: Risperidone 6 mg (Acute) - Risperidone 6 mg (Extension) Active Control 2 Interventions

Participants will be treated for a total of 12 weeks. Participants will receive risperidone 6 mg QD in the acute treatment period from Week 1-6 followed by risperidone 6 mg QD in the extension treatment period from Week 7-12 and participants will simultaneously receive MK-8189-matching placebo QD from Week 1-12.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of once-monthly Risperidone ISM® in the treatment of schizophrenia: Results from a 12-month open-label extension study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Risperidone: an analysis of the first three years in general use. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Treatment compliance in veterans administration schizophrenia spectrum patients treated with risperidone long-acting injectable. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Symptom control, functioning and satisfaction among Swiss patients treated with risperidone long-acting injectable. [2014]

5. Spain pubmed.ncbi.nlm.nih.gov

[Long-term relapse prevention with risperidone in 215 schizophrenic patients]. [2019]

6. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Risperidone in the treatment of schizophrenia. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Classics in Chemical Neuroscience: Risperidone. [2019]

8. Thailand pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of risperidone in chronic schizophrenic Thai patients. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Long-term treatment with long-acting risperidone in Korean patients with schizophrenia. [2013]

10. China pubmed.ncbi.nlm.nih.gov

[Animal models of schizophrenia using different laboratory mouse strains]. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Neurochemical changes underlying schizophrenia-related behavior in a modified forced swim test in mice. [2019]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Lurasidone reverses MK-801-induced impairment of learning and memory in the Morris water maze and radial-arm maze tests in rats. [2019]

13. Austria pubmed.ncbi.nlm.nih.gov

Proteome analysis after co-administration of clozapine or haloperidol to MK-801-treated rats. [2022]

14. Austria pubmed.ncbi.nlm.nih.gov

[3H]MK-801 binding sites in postmortem brain regions of schizophrenic patients. [2019]