Adults 18 to 60, any sex, with Bipolar I Disorder. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Experience One or More Adverse Events (AEs)Primary· Up to 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Group
Value
95% CI
Panel A: MK-8189 24 mg
9
Panel A: Placebo
4
Panel C: MK-8189 8 mg
1
Panel C: 16 mg MK-8189
4
Panel C: MK-8189 24 mg
6
Panel C: MK-8189 12 mg
0
Panel C: Placebo
1
Number of Participants Who Discontinue Study Treatment Due to an AEPrimary· Up to 14 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Group
Value
95% CI
Panel A: MK-8189 24 mg
3
Panel A: Placebo
1
Panel C: MK-8189 8 mg
0
Panel C: MK-8189 16 mg
0
Panel C: MK-8189 24 mg
0
Panel C: MK-8189 12 mg
0
Panel C: Placebo
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 28 days..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The goal of this study is to evaluate the safety and tolerability of MK-8189 in participants with stable bipolar I disorder. There was no hypothesis testing in this study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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· completed
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· Phase 1
· completed
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· Phase 1
· completed
NCT05227118 — MK-8189 Safety and Tolerability in Participants With Alzheimer's Disease With or Without Symptoms of Agitation-Aggressio
· Phase 1
· completed
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· Phase 1
· completed
Other recruiting trials for Bipolar I Disorder
Currently open trials in the same condition.
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· active not recruiting
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· NA
· recruiting
NCT05648591 — Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
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· recruiting
NCT05427123 — Children's Bipolar Network Treatment Trial I
· recruiting
Other Merck Sharp & Dohme LLC trials
Trials by the same sponsor.
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· Phase 2
· not yet recruiting
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· recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527
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· not yet recruiting
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 17 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06273774.