EICHOR
● Completed
Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)
Condition: Schizophrenia · Sponsor: Merck Sharp & Dohme LLC
About this study
The purpose of this study was to evaluate the efficacy and safety of elpipodect 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 elpipodect 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 elpipodect 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 elpipodect 8 mg treatment arm. Participants enrolled before Amendment 4 who were assigned to elpipodect 8 mg QD remained on that dose regimen per protocol.
This description comes directly from the study's public registry record.
Talk to the study team
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (121)
| 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 | — |
| Schuster Medical Research Institute ( Site 1023) | Sherman Oaks, California, United States | — |
| Behavioral Clinical Research ( Site 1058) | Hollywood, Florida, United States | — |
+ 109 more locations — full list on the registry record.
Follow this study
Save your interest here for when the public record changes — results posted, or the study's status changes. Email alerts for this study aren't switched on yet.
We keep this only about this public record, and never email you without alerts being switched on. Want it removed at any time? Email hello@eichor.com. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT04624243