Trial Purpose

The purpose of this study is to evaluate the efficacy and safety of MK-8189 at a range of doses (8 mg, 16 mg, and 24 mg once daily) 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 are the following: (1) MK-8189 24 mg is superior to placebo in reducing the Week 6 mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (2) MK-8189 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 MK-8189 8 mg treatment arm. Participants enrolled before Amendment 4 that have been assigned to 8 mg MK-8189 will remain on 8 mg MK-8189 per protocol.

View full trial information on Clinicaltrials.gov

CLINICALTRIALS.GOV IDENTIFIER

NCT04624243

EudraCT Number

2020-000094-24

When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.

Resources

Eligibility

Only a qualified healthcare professional can determine if you are eligible to take part in a clinical trial. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon

Conditions

Schizophrenia

Age Range Icon

Age Range

18 - 55

Sex Icon

Sex

All

About the trial

Trial phase Icon Current trial phase

Trial Phase 2

In Phase 2 trials, researchers try to find out if a treatment works in about 100 to 500 participants – usually people who have the health condition the treatment is intended to treat. In vaccine trials, the participants are usually healthy. Phase 2 trials may happen in a doctor’s office, a clinic, or a hospital.

Trial start Icon Trial start and end dates
  • Trial start date December 15, 2020
  • Estimated primary completion date July 15, 2024
  • Estimated trial completion date July 15, 2024

Trial locations

Locations shown may have changed in some cases. Please call the number listed in the location results to confirm the nearest trial site. Talk with a trial site member for more information.

What can you do next?

If you think this clinical trial might be a good fit and you are interested in taking part, take the next step to see if you are eligible.

Discuss with your doctor or care team

Print this page with details about the trial or email it to your doctor to discuss the clinical trial during your next visit.

Get help talking with your doctor or care team

CLINICALTRIALS.GOV IDENTIFIER

NCT04624243

EudraCT Number

2020-000094-24

When you talk with your doctor or clinical trial team member, please have the trial identifier number or the EudraCT number available.

Taking part in a clinical trial is an important decision

If you are considering joining a clinical trial, first learn as much as you can about:

  • The investigational treatment that is being studied
  • What the risks and possible benefits are for participants

Talk to your doctor about the clinical trial before you decide to join.

Read our “What to Consider” page for more questions to ask and think about