MK-8189 for Schizophrenia

No longer recruiting at 153 trial locations

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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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, MK-8189, to determine its effectiveness for individuals experiencing an acute episode of schizophrenia. Researchers aim to discover if different doses of MK-8189 improve symptoms more effectively than a placebo (a substance with no active drug) or an existing treatment called Risperidone. Individuals who have had schizophrenia for at least a year and are currently experiencing a sudden worsening of symptoms might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In earlier studies, MK-8189 was found to be safe. No participants died or experienced serious health problems during the trial. Participants generally tolerated MK-8189 well at doses of 8 mg, 16 mg, and 24 mg.

Risperidone, the comparator in this study, is already FDA-approved for treating schizophrenia and has a well-established safety record. In the study examined, some participants taking risperidone experienced serious health issues, but these were linked to alcohol use, not the medication itself.

Both treatments have demonstrated general safety, with MK-8189 showing no serious problems in the reported research. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

MK-8189 is unique because it offers a new approach to treating schizophrenia with its different dosing options and potential for flexible treatment plans. Unlike standard antipsychotic treatments like Risperidone, which primarily target dopamine receptors, MK-8189 may provide diverse dosing regimens, allowing for personalized treatment. This could mean better management of symptoms and potentially fewer side effects, making it an exciting development for both patients and healthcare providers.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Research has shown that MK-8189, a new medication under study in this trial, may help treat schizophrenia. It improved symptoms more than a placebo, with noticeable changes in the overall condition after just four weeks. MK-8189 might reduce both positive symptoms (such as hallucinations) and negative symptoms (such as emotional flatness) of schizophrenia.

Risperidone, another treatment option in this trial, is a well-researched medication for schizophrenia. It has proven more effective than a placebo, showing significant symptom improvement and safety for long-term use. Risperidone is known to quickly reduce symptoms in individuals experiencing severe episodes of schizophrenia. This trial studies both treatments for their potential to improve the lives of people with schizophrenia. ^{1 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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

Have an illness duration for schizophrenia of at least 1 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Placebo and MK-8189 24 mg Experimental Treatment 3 Interventions

Participants received placebo QD from Weeks 1 to 6 and MK-8189 24 mg from Weeks 7 to 12, with 2 weeks of follow-up.

Group II: MK-8189 8 mg Experimental Treatment 2 Interventions

Participants received MK-8189 8 mg QD from Weeks 1 to 12, with 2 weeks of follow-up

Group III: MK-8189 24 mg Experimental Treatment 2 Interventions

Participants received MK-8189 24 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

Group IV: MK-8189 16 mg Experimental Treatment 2 Interventions

Participants received MK-8189 16 mg QD from Weeks 1 to 12, with 2 weeks of follow-up.

Group V: Risperidone 6 mg 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.

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38851166/

Effects of PDE10A inhibitor MK-8189 in people with an ... MK-8189 demonstrated a trend towards improvement versus placebo for change-from-baseline in PANSS total score after 4 weeks (difference = -4.7 [ ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0920996424002093

Effects of PDE10A inhibitor MK-8189 in people with an ... The primary efficacy endpoint was mean change from baseline in PANSS total score after 4 weeks for MK-8189 versus placebo (with the corresponding primary ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04624243?intr=MK-8189&rank=4

NCT04624243 | Efficacy and Safety of MK-8189 in ... The purpose of this study was to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult ...

4. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.2c01521

Discovery of MK-8189, a Highly Potent and Selective PDE10A ... PDE10A inhibition has the potential to treat positive symptoms of schizophrenia, improve cognition, and address some of the limitations of current therapies.

5. merckclinicaltrials.com merckclinicaltrials.com/trial/nct04624243/

Efficacy and Safety of MK-8189 in Participants With an Acute ... The purpose of this study is to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily) in adult participants ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04624243

Efficacy and Safety of MK-8189 in Participants With an ... The purpose of this study was to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily [QD]) in adult ...