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

NCT04624243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 499

Last updated 2026-04-29

Study results available
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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.

Conditions

Interventions

DRUG

Elpipodect

MK-8189 administered QD at a dose of 8 mg, 16 mg, or 24 mg via oral tablet.

DRUG

Risperidone

Risperidone administered QD at a dose of 6 mg via oral capsule.

DRUG

Placebo to MK-8189

MK-8189-matching placebo administered QD via oral tablet.

DRUG

Placebo to risperidone

Risperidone-matching placebo administered QD via oral capsule.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2024-06-21
Completion
2024-06-21
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Japan
  • Latvia
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04624243 on ClinicalTrials.gov