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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
The main inclusion
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 17 days
Awards & highlights

Study Summary

This trial is testing a new drug for safety and how well it is tolerated by people with schizophrenia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 17 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 17 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants discontinuing study treatment due to an AE
Number of participants experiencing an Adverse Event (AE)

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338
18%
Akathisia
16%
Nausea
16%
Headache
9%
Dystonia
8%
Diarrhoea
8%
Vomiting
8%
Sedation
8%
Anxiety
7%
Decreased appetite
7%
Somnolence
7%
Insomnia
6%
Dyspepsia
3%
Dizziness
2%
Weight increased
2%
Fatigue
1%
Agitation
1%
Lethargy
100%
80%
60%
40%
20%
0%
Study treatment Arm
MK-8189
Risperidone
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-8189 Panel CExperimental Treatment1 Intervention
Participants will receive MK-8189 48 mg on Days 1-2 and 80 mg on Day 3 based on safety and tolerability.
Group II: MK-8189 Panel A-1Experimental Treatment1 Intervention
Participants will receive MK-8189 48 mg on Day 1 and 80 mg on Day 2.
Group III: MK-8189 Panel AExperimental Treatment1 Intervention
Participants will receive MK-8189 starting at 48 mg on Day 1 and 60 mg on Day 2.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive MK-8189-matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-8189
2020
Completed Phase 2
~640

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,055,004 Total Patients Enrolled
23 Trials studying Schizophrenia
2,633 Patients Enrolled for Schizophrenia
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,811 Total Patients Enrolled
28 Trials studying Schizophrenia
4,285 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are involved in this experiment?

"Indeed, according to clinicaltrials.gov the medical trial is currently inviting participants; it was first posted on July 12th 2022 and most recently modified on November 16th of that year. This study needs 54 volunteers recruited from three different sites."

Answered by AI

What qualifications must a person meet in order to join this experiment?

"This medical study is accepting 54 candidates aged between 18 and 55 with a diagnosis of schizophrenia. The main criteria for inclusion in this experiment includes: [list the criteria here]."

Answered by AI

Has the FDA endorsed MK-8189 for public usage?

"With limited efficacy and safety data, MK-8189 received a score of 1 on the Power scale."

Answered by AI

Is this research open to septuagenarians?

"This medical research is enrolling participants aged 18-55 years old."

Answered by AI

Is this research currently accepting volunteers?

"Affirmative. The clinical trial is actively looking for participants, as indicated by the information hosted on clinicaltrials.gov. This medical study was initially posted on July 12th 2022 and its details were updated most recently on November 16th 2022. Approximately 54 patients need to be recruited at 3 separate sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)
2022. "A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05406440.
~19 spots leftby Apr 2025
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