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New schizophrenia drug shows promise in early trial

NCT ID NCT03055338

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new medicine called MK-8189 in 224 adults having an acute episode of schizophrenia. Participants received either MK-8189, a placebo (inactive pill), or an active control (risperidone) for 4 weeks. The main goal was to see if MK-8189 reduces schizophrenia symptoms better than placebo, as measured by a standard symptom scale. The study also monitored safety and side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

224 people

The number who actually took part.

Started

Mar 2017

Finished

Jan 2018

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 50 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: * 18 to 50 years of age at Screening * Male * Female not of reproductive potential (e.g., postmenopausal or has had a hysterectomy), or agrees to practice abstinence or use acceptable contraception * Meets the diagnostic criteria for schizophrenia according to the DSM-5 criteria, or has a past diagnosis of schizophrenia with the onset of the first episode being \>=1 year prior to study entry, and has illness duration of \<=20 years * Is confirmed to be experiencing an acute episode of schizophrenia * Minimum PANSS score \>= 80 at Screening * Has a score of \>=4 in 3 or more of the following items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) in the positive subscale of the PANSS at Screening * Has a CGI-S score \>= 4 at Screening * Is able to taper off psychotropic medications without significant destabilization or increased suicidality * Has responded positively to an antipsychotic medication other than clozapine in a prior psychotic episode * Has an identified responsible external contact person who has regular contact (no less than once per week) with the participant Exclusion Criteria: * Is currently under involuntary commitment because he/she is considered a danger to himself/herself or others * Is unwilling to remain hospitalized for the duration of trial treatment * Is currently participating in or has participated in an interventional clinical research study \<=6 months prior to Screening, or has participated in more than one interventional clinical trial research study within 12 months prior to Screening * Is unwilling to allow audio/video taping of the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders (MINI) and/or PANSS interview at Screening and Baseline * Is currently being treated with and benefiting from medications with a moderate or strong inhibiting or inducing effect on Cytochrome P450 (CYP) 3A and/or CYP2C9 and/or sensitive substrates of CYP2B6 * Has a history of malignancy \<= 5 years except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * Has a body mass index \<18.5 or \>40 kg/m˄2 * Has a history of treatment-resistant schizophrenia * Has a prolactin laboratory value of \>= 5 times the upper limit of normal at Screening * Has a known history or clinical evidence of clinically significant hepatic, cardiovascular, or renal disease, or of untreated narrow-angle glaucoma- Has ever been diagnosed with epilepsy or had any seizure disorder beyond one childhood febrile seizure * Has known serological evidence of human immunodeficiency virus (HIV) antibody * Has a history of neuroleptic malignant syndrome * Has a current diagnosis other than schizophrenia, or a comorbid diagnosis primarily responsible for current symptoms and functional impairment * Has a known history of borderline personality disorder, antisocial personality disorder, or bipolar disorder * Has a known history of traumatic brain injury, or Alzheimer's disease or another form of dementia * Currently meets DSM-5 criteria for substance abuse or alcohol use disorder * Is at imminent risk of self-harm or harm to others

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Conditions

The condition(s) this trial relates to.

psychiatric disorder schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

As listed by the trial registrant

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

Schizophrenia, acute episode

Contacts and locations

Locations

  • Alexian Center for Psychiatric Research ( Site 0015)

    Hoffman Estates, Illinois, 60169, United States

  • Altea Research Institute ( Site 0017)

    Las Vegas, Nevada, 89102, United States

  • Artemis Institute for Clinical Research ( Site 0027)

    San Diego, California, 92103, United States

  • Aspire Health Partners ( Site 0016)

    Orlando, Florida, 32810, United States

  • Atlanta Center For Medical Research ( Site 0056)

    Atlanta, Georgia, 30331, United States

  • Behavioral Research Specialists, LLC ( Site 0006)

    Glendale, California, 91206, United States

  • CBH Health, LLC ( Site 0022)

    Gaithersburg, Maryland, 20877, United States

  • CITRIALS ( Site 0013)

    Bellflower, California, 90706, United States

  • CNRI - Los Angeles, LLC ( Site 0026)

    Pico Rivera, California, 90660, United States

  • Clinical Research Centers of America, LLC ( Site 0038)

    Oakland Park, Florida, 33334, United States

  • Collaborative Neuroscience Network, LLC ( Site 0046)

    Torrance, California, 90502, United States

  • Collaborative Neuroscience Network, LLC ( Site 0057)

    Garden Grove, California, 92845, United States

  • Comprehensive Clinical Development ( Site 0049)

    Cerritos, California, 90703, United States

  • InSite Clinical Research ( Site 0033)

    DeSoto, Texas, 75115, United States

  • Lake Charles Clinical Trials, LLC ( Site 0040)

    Lake Charles, Louisiana, 70629, United States

  • Larkin Community Hospital Behavioral Health Services ( Site 0020)

    Hollywood, Florida, 33021, United States

  • Midwest Clinical Research Unit ( Site 0041)

    Dayton, Ohio, 45417, United States

  • NRC Research Institute ( Site 0043)

    Orange, California, 92868, United States

  • Pillar Clinical Research, LLC ( Site 0004)

    Richardson, Texas, 75080, United States

  • Precise Research Centers ( Site 0018)

    Flowood, Mississippi, 39232, United States

  • Psych Care Consultants Research ( Site 0025)

    St Louis, Missouri, 63128, United States

  • Radiant Research - Atlanta ( Site 0008)

    Atlanta, Georgia, 30328, United States

  • Radiant Research -CliniLabs ( Site 0037)

    New York, New York, 10019, United States

  • Schuster Medical Research Institute ( Site 0032)

    Sherman Oaks, California, 91403, United States

  • St. Louis Clinical Trials, LLC ( Site 0012)

    St Louis, Missouri, 63141, United States

  • Synergy East ( Site 0003)

    Lemon Grove, California, 91945, United States

  • Woodland International Research Group, LLC ( Site 0001)

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest, LLC ( Site 0014)

    Rogers, Arkansas, 72758, United States