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A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

A Multiple Dose Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8189 in Participants With Bipolar I Disorder

NCT06273774•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meets diagnostic criteria for bipolar I disorder, manic or mixed features according to the Diagnostic and statistical manual of Mental Disorders TR (DSM-5 TR) and considered to be in a non-acute phase of their illness.
•History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder.
•Body mass index is 18 and 40 kg/m\^2, inclusive.
•If currently taking an antipsychotic, is able to discontinue use at least 5 days prior to study start and the duration of the study.

Exclusion Criteria

•Untreated or uncompensated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases.
•Evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than those specified for inclusion.
•History of cancer (malignancy).
•Evidence or history of mental retardation, borderline personality disorder, or organic brain syndrome.
•History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
•Substance-induced psychotic disorder or behavioral disturbance.
•DSM-5 TR defined substance use disorder within 3 months of screening.
•History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
•Positive test(s) for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
•Major surgery or donation/loss of 1 unit of blood within 4 weeks prior to screening.
+1 more criteria

Locations (3)

Woodland International Research Group-Clinical Research ( Site 0009)

Little Rock, Arkansas, United States

Atlanta Center for Medical Research ( Site 0001)

Atlanta, Georgia, United States

Hassman Research Institute Marlton Site ( Site 0006)

Marlton, New Jersey, United States

Key Dates

Start Date

April 8, 2024

Primary Completion Date

August 21, 2024

Completion Date

August 21, 2024

Last Updated

August 17, 2025

Enrollment

ACTUAL participants

Conditions

Bipolar I Disorder

Interventions

MK-8189

DRUG

Placebo

DRUG

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

NCT05303064

SchizophreniaBipolar I Disorder

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RECRUITINGPHASE3

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

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Bipolar DisorderBipolar Depression+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

Inclusion Criteria

Exclusion Criteria

Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

Sequential Multiple Assignment Randomized Trial for Bipolar Depression

ERG Components in Schizophrenia and Bipolar Disorder Type I

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)