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A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of MK-8189 in Participants With Schizophrenia (MK-8189-014)

A Multiple Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, PK and the Effect of MK-8189 on QTc in Participants With Schizophrenia

NCT05406440•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to assess the safety and tolerability of multiple ascending doses of MK-8189 in participants with schizophrenia.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria with the onset of the first episode being no less than 2 years prior to screening and monotherapy with antipsychotics for treatment should be indicated.
•Is in the non-acute phase of their illness and clinically stable for 3 months prior to screening as demonstrated by: 1) no clinically significant change in dose of prescribed antipsychotic medication, or clinically significant change in antipsychotic medication to treat symptoms of schizophrenia for two months prior to screening; 2) no increase in level of psychiatric care due to worsening of symptoms of schizophrenia for three months prior to screening.
•Has a history of receiving and tolerating antipsychotic medication within the usual dose range employed for schizophrenia.
•Is able to discontinue the use of all antipsychotic medication at least 5 days or 3 half-lives (whichever is longer) prior to Day -1 and during the study period.

Exclusion Criteria

•Is at imminent risk of self-harm.
•Has a history of cancer (malignancy). Exceptions: 1) adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix; 2) malignancies which have been successfully treated ≥10 years prior to the prestudy (screening) visit; 3) highly unlikely to sustain a recurrence for the duration of the study.
•Has evidence or history of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria within one month of screening.
•Has evidence or history of mental retardation, borderline personality disorder, anxiety disorder, or organic brain syndrome.
•Has a history of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia.
•Has a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
•Has a DSM-5 defined substance use disorder (excluding nicotine and caffeine) within 3 months of screening.
•Has a history of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures.
•Has a clinically significant history or presence of sick sinus syndrome, first, second, or third degree atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged corrected QT (QTc) interval, or conduction abnormalities.
•Meets any of the following cardiac parameters: a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), uncorrected hypokalemia or hypomagnesemia, or is taking concomitant medications that prolong the QT/QTc interval.
+7 more criteria

Locations (3)

Collaborative Neuroscience Research, LLC ( Site 0004)

Garden Grove, California, United States

California Clinical Trials Medical Group managed by PAREXEL ( Site 0002)

Glendale, California, United States

Hassman Research Institute Marlton Site ( Site 0003)

Marlton, New Jersey, United States

Key Dates

Start Date

July 12, 2022

Primary Completion Date

February 24, 2023

Completion Date

February 24, 2023

Last Updated

July 25, 2024

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

MK-8189

DRUG

Placebo

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 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: July 25, 2024Data 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 Schizophrenia (MK-8189-014)

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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