Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heart safety check for new schizophrenia drug

NCT ID NCT05893862

Knowledge-focused Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checked whether a high dose of the experimental drug MK-8189 (elpipodect) affects heart rhythm in people with schizophrenia. 107 participants received the drug, a placebo, and an active control in a crossover design. The main goal was to see if the drug causes a dangerous heart rhythm change called QTc prolongation. This was a Phase 1 safety study, not a treatment trial.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

107 people

The number who actually took part.

Started

Jun 2023

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets diagnostic criteria for schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria. * Is in the non-acute phase of their illness. * Has a history of receiving and tolerating antipsychotics medication within the usual dose range employed for schizophrenia. * Participants with hypothyroidism, diabetes, high blood pressure, chronic respiratory conditions or other medical conditions could be considered if their condition is stable. Exclusion Criteria: * History of a primary DSM-5 axis I psychiatric diagnosis other than schizophrenia or schizoaffective disorder per the allowed DSM-5 criteria. * History of intellectual disability, borderline personality disorder, anxiety disorder, or organic brain syndrome. * History of neuroleptic malignant syndrome or moderate to severe tardive dyskinesia (TD). * History of seizure disorder beyond childhood or is receiving treatment with any anticonvulsant to prevent seizures. * History of cancer. * History or presence of sick sinus syndrome, atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QTc interval, or conduction abnormalities. * History of risk factors for Torsades de Pointes (e.g., heart failure/cardiomyopathy or family history of long QT syndrome). * History of frequent syncope, vasovagal episodes, or epileptic seizures. * Family history of sudden cardiac death. * Has a positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV). * Had major surgery, donated, or lost 1 unit of blood within 4 weeks prior to the pre-study visit.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Schizoaffective disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • California Clinical Trials Medical Group managed by PAREXEL-PAREXEL International ( Site 0003)

    Glendale, California, 91206, United States

  • Hassman Research Institute Marlton Site ( Site 0001)

    Marlton, New Jersey, 08053, United States

  • NRC Research Institute ( Site 0004)

    Orange, California, 92868, United States

  • Velocity Clinical Research, Hallandale Beach ( Site 0002)

    Hallandale, Florida, 33009, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.