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NCT03055338 · ClinicalTrials.gov registry record · Phase 2
An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)
A Phase 2 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 224
- Enrollment target
NCT03055338: Completed Phase 2 study, sponsored by Merck Sharp & Dohme.
NCT03055338 is a Phase 2 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 224 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055338, a Phase 2 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 224 participants
- Enrollment target
Study Summary
This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5). This study will be up to 7 weeks in duration, with up to 7 site visits for each participant. The study will consist of a Screening/tapering period (up to one week long), a 4-week treatment period, and a 14-day follow-up period. The primary objective will be to assess symptoms of schizophrenia at 4 weeks, and to assess safety and tolerability during treatment and post-treatment follow-up. The secondary objective will be to assess the severity of schizophrenia at 4 weeks. The primary hypothesis is that elpipodect is superior to placebo in reducing the overall symptoms of schizophrenia as assessed by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score after 4 weeks of treatment.
Primary Outcome
The LSM change from baseline at week 4 was assessed for PANSS total score. The PANSS assesses the severity of schizophrenia symptoms through a clinician-rated inventory of 30 items organized in 3 subscales: 1) positive subscale (7 items); 2) negative subscale (7 items); and 3) general psychopathology subscale (16 items). For each item, symptoms are scored from 1 (absent) to 7 (extreme) and sum to a total PANSS score (range: 30-210). Higher scores reflect more severe symptoms of schizophrenia. Fu
Interventions
- DRUG Risperidone
- DRUG Elpipodect
- DRUG Placebo matching MK-8189
- DRUG Placebo matching risperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2018-01-09 |
| Phase | Phase 2 |
What the finished NCT03055338 record still lists
NCT03055338 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% higher).
The record links to 0 conditions, and to 4 interventions - of which Risperidone is the first listed.
NCT03055338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03055338 about?
NCT03055338 is a clinical study titled "An Active-Controlled Early Phase Study of Elpipodect (MK-8189) in Adults With Schizophrenia (MK-8189-005)". This will be a randomized, placebo-controlled, parallel-group, multi-site, double-blind trial of elpipodect compared with placebo, using Risperidone as an active control. The participants will be adult subjects experiencing an acute episode of schizophrenia, according to the criteria specified in th...
What is the current status of trial NCT03055338?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2017-03-08. Estimated completion is 2018-01-09.
What interventions are being tested in trial NCT03055338?
The interventions under investigation include: Risperidone (DRUG), Elpipodect (DRUG), Placebo matching MK-8189 (DRUG), Placebo matching risperidone (DRUG).
Who is sponsoring clinical trial NCT03055338?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03055338's enrollment target sits among peer trials
224 269th of 2000 higher than 1,727 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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