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MK-8189 for Schizophrenia

Phase 1

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

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 panels d, f: predose and up to 24 hours postdose on days 1, 4, 7 and 13; panels e, g: predose and up to 24 hours postdose on days 1, 4, and 10

Awards & highlights

Summary

This trial tests a new medication called MK-8189 to see if it's safe and how it behaves in the body. It involves young adults with schizophrenia and elderly participants, both with and without schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ panels d, f: predose and up to 24 hours postdose on days 1, 4, 7 and 13; panels e, g: predose and up to 24 hours postdose on days 1, 4, and 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~panels d, f: predose and up to 24 hours postdose on days 1, 4, 7 and 13; panels e, g: predose and up to 24 hours postdose on days 1, 4, and 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and panels d, f: predose and up to 24 hours postdose on days 1, 4, 7 and 13; panels e, g: predose and up to 24 hours postdose on days 1, 4, and 10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1 & 2: Number of Participants Discontinuing Study Treatment Due to an AE

Part 1 & 2: Number of Participants Who Experienced an Adverse Event (AE)

Secondary study objectives

Part 1: Apparent Terminal Half-life (t1/2) of MK-8189

Part 1: Area Under the Concentration Time-curve From Hour 0 to 24 Hours (AUC0-24hr) of MK-8189

Part 1: Clearance (CL) of MK-8189

+11 more

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338

18%

Weight increased

13%

Sedation

11%

Headache

Dizziness

Akathisia

Nausea

Fatigue

Dyspepsia

Lethargy

Agitation

Schizophrenia

Somnolence

Decreased appetite

Vomiting

Anxiety

Alcohol poisoning

100%

80%

60%

40%

20%

Study treatment Arm

Risperidone

MK-8189

Placebo

Trial Design

9Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 2 (Panel G) MK-8189Experimental Treatment1 Intervention

Healthy elderly adult participants receive MK-8189 titrated from 16 mg to 24 mg QD, orally, over the course of 10-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group II: Part 2 (Panel F) MK-8189Experimental Treatment1 Intervention

Healthy elderly adult participants receive MK-8189 titrated from 8 mg to 24 mg QD, orally, over the course of a 13-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group III: Part 2 (Panel E) MK-8189Experimental Treatment1 Intervention

Elderly adult participants with schizophrenia receive MK-8189 titrated from 16 mg to 24 mg QD, orally, over the course of 10-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group IV: Part 2 (Panel D) MK-8189Experimental Treatment1 Intervention

Elderly adult participants with schizophrenia receive MK-8189 titrated from 8 mg to 24 mg QD, orally, over the course of a 13-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group V: Part 1 (Panel C) MK-8189Experimental Treatment1 Intervention

Young adult participants with schizophrenia receive MK-8189 titrated from 8 mg to 24 mg QD, orally, over a course of 7-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panels.

Group VI: Part 1 (Panel B) MK-8189Experimental Treatment1 Intervention

Young adult participants with schizophrenia receive MK-8189 titrated up to 24 mg QD, orally, over a course of 7-day treatment period with starting doses based on safety and tolerability of previous starting dose in previous panel.

Group VII: Part 1 (Panel A) MK-8189Experimental Treatment1 Intervention

Young adult participants with schizophrenia receive MK-8189 titrated from 16 mg to 24 mg once daily (QD), orally, over a course of 7-day treatment.

Group VIII: Part 2 (Panels D, E, F, G) PlaceboPlacebo Group1 Intervention

Oral tablets of dose-matched placebo to total daily dose of MK-8189.

Group IX: Part 1 (Panels A, B, C) PlaceboPlacebo Group1 Intervention

Oral tablets of dose-matched placebo to total daily dose of MK-8189.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-8189

2020

Completed Phase 2

~640

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,582,516 Total Patients Enrolled

34 Trials studying Schizophrenia

8,896 Patients Enrolled for Schizophrenia

Merck Sharp & Dohme LLCLead Sponsor

3,950 Previous Clinical Trials

5,174,920 Total Patients Enrolled

23 Trials studying Schizophrenia

2,623 Patients Enrolled for Schizophrenia

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,834 Previous Clinical Trials

8,079,717 Total Patients Enrolled

28 Trials studying Schizophrenia

4,275 Patients Enrolled for Schizophrenia

~13 spots leftby Sep 2025

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