Efficacy and Safety of Elpipodect (MK-8189) in Participants With an Acute Episode of Schizophrenia (MK-8189-008)

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT04624243

Run by

Merck Sharp & Dohme LLC

People needed

499

Starts

2020-12-15

Expected to finish

2024-06-21

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The main inclusion criteria include, but are not limited to the following:
• Meet the diagnostic criteria for schizophrenia according to the DSM-5
• Have an illness duration for schizophrenia of at least 1 year
• Be confirmed to be experiencing an acute episode of schizophrenia as evidenced by ALL of the following: (a) onset of the current acute episode is ≤6 weeks before screening (b) current symptoms represent a marked and substantial worsening compared with the participant's usual symptomatic state prior to the current acute episode, and are associated with diminished functional ability (c) in need of increased psychiatric attention to treat worsening acute episode symptoms
• Have a CGI-S score of ≥4 (moderately ill) at screening and baseline
• Have an identified responsible person referred to as the "external contact person" who has agreed to provide information about the participant's location if needed during outpatient portion of the study. The site personnel must consider this identified responsible person a reliable contact person, and the contact person must have regular contact with the participant (defined at screening as direct contact no fewer than 3 times per week), and with the expectation that this frequency of contact would continue (either in person or via other contact method), throughout duration of the study, including the follow-up period)

You may not qualify if…

• The main exclusion criteria include, but are not limited to the following:
• Has a primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment
• Meets criteria for moderate to severe substance use disorder within past 6 months prior to screening (excluding those related to caffeine or nicotine)
• Has a known history of the following: (a) borderline personality disorder, anti-social personality disorder, or bipolar disorder (b) traumatic brain injury causing ongoing cognitive difficulties, Alzheimer's Disease, or another form of dementia, or any chronic organic disease of the central nervous system (c) intellectual disability of a severity that would impact ability to participate in the study
• Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse
• Is or was under involuntary commitment for the acute episode, because the participant is considered a danger to themselves or others
• Has a history of treatment resistance exhibited by any of the following: (a) no or minimal response to at least 2 periods of treatment lasting 6 weeks or longer, with antipsychotic agents at the maximally tolerated dose. Participants who have responded to antipsychotics only when paired with clozapine are considered treatment-resistant (b) history of electroconvulsive therapy (ECT) treatment for treatment-resistant schizophrenia within the past 6 months (c) past or current use of clozapine as single or adjunctive therapy for schizophrenia within the past 3 months
• Is currently participating in or has participated in another clinical study and received an experimental or investigational drug agent within 3 months prior to screening visit of this current study and has participated in no more than 2 studies in the past 2 years

Where it is running

• 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
• Research Centers of America ( Hollywood )-Central Nervous System (CNS) ( Site 1065) — Hollywood, Florida, United States
• Premier Clinical Research Institute ( Site 1049) — Miami, Florida, United States
• Behavioral Clinical Research , Inc ( Site 1013) — Miami Lakes, Florida, United States
• Fort Lauderdale Behavioral Health Center ( Site 1028) — Oakland Park, Florida, United States
• Health Synergy Clinical Research ( Site 1051) — Stuart, Florida, United States
• Atlanta Center For Medical Research ( Site 1022) — Atlanta, Georgia, United States
• CenExel iResearch, LLC ( Site 1039) — Decatur, Georgia, United States
• Ascension Saint Elizabeth ( Site 1000) — Chicago, Illinois, United States
• Uptown Research Institute ( Site 1052) — Chicago, Illinois, United States
• Pillar Clinical Research, LLC ( Site 1038) — Chicago, Illinois, United States
• Benchmark Research ( Site 1054) — Shreveport, Louisiana, United States
• CBH Health ( Site 1044) — Gaithersburg, Maryland, United States
• Massachusetts General Hospital ( Site 1035) — Boston, Massachusetts, United States
• Pillar Clinical Research ( Site 1047) — Bentonville, Arkansas, United States

Full record on ClinicalTrials.gov

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