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A Phase 2B Randomized, Double-Blind, Placebo- and Active-Controlled Trial of the Efficacy and Safety of MK-8189 in Participants Experiencing an Acute Episode of Schizophrenia
The purpose of this study was to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily \[QD\]) in adult participants who have an acute episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria. The primary hypotheses were the following: (1) that MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score, and (2) that MK-8189 16 mg is superior to placebo in reducing the Week 6 mean change from baseline in PANSS total score. With Amendment 4, enrollment was changed to approximately 500 participants with removal of the MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to MK-8189 8 mg QD remained on that dose regimen per protocol.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
No
Pillar Clinical Research ( Site 1047)
Bentonville, Arkansas, United States
Woodland International Research Group, LLC ( Site 1002)
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC ( Site 1036)
Rogers, Arkansas, United States
CITRIALS ( Site 1010)
Bellflower, California, United States
ProScience Research Group ( Site 1046)
Culver City, California, United States
Collaborative Neuroscience Research, LLC ( Site 1041)
Garden Grove, California, United States
Behavioral Research Specialists, LLC ( Site 1032)
Glendale, California, United States
CITRIALS ( Site 1016)
Riverside, California, United States
Artemis Institute for Clinical Research ( Site 1019)
San Diego, California, United States
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) ( Site 103
San Diego, California, United States
Start Date
December 15, 2020
Primary Completion Date
June 21, 2024
Completion Date
June 21, 2024
Last Updated
February 5, 2026
499
ACTUAL participants
MK-8189
DRUG
Risperidone
DRUG
Placebo to MK-8189
DRUG
Placebo to risperidone
DRUG
Lead Sponsor
Merck Sharp & Dohme LLC
NCT07455929
NCT06740383
Data Source & Attribution
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