At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Elpipodect, Risperidone, and 2 other interventions for Schizophrenia. Completed, enrolled 499 participants across 121 sites in 12 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
MK-8189 administered QD at a dose of 8 mg, 16 mg, or 24 mg via oral tablet.
Risperidone administered QD at a dose of 6 mg via oral capsule.
MK-8189-matching placebo administered QD via oral tablet.
Risperidone-matching placebo administered QD via oral capsule.