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New pill aims to ease schizophrenia psychosis

NCT ID NCT05227703

Symptom relief Sponsor: AbbVie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two doses of a new drug called emraclidine (CVL-231) in 391 adults with schizophrenia who were having a sudden worsening of psychotic symptoms. Participants took the drug or a placebo daily for 6 weeks. The main goal was to see if the drug reduced symptoms like hallucinations and delusions better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Emraclidine (CVL-231)
What this could lead to
If it works, this could point toward a new treatment option for acute psychotic episodes in schizophrenia.
What could go wrong
This is a Phase 2 trial, so results are still early. The drug may not prove effective or could have side effects. It is not a cure.

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

391 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 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 65 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: * Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders. * CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline. * PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline. * Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF. * Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period. * Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs). * Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements. Exclusion Criteria: * Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory. * Any of the following: * Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks) * History of response to clozapine treatment only or failure to respond to clozapine treatment * Any of the following regarding history of schizophrenia: * Time from initial onset of schizophrenia \<2 years based on prior records or participant self-report * Presenting with an initial diagnosis of schizophrenia * Presenting for the first time with an acute psychotic episode requiring treatment * Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline. * Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial. * Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results * Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF. * Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment. * Any condition that could possibly affect drug absorption. * Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial. * Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening. * Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.

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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

Contacts and locations

Locations

  • Atlanta, Georgia

    Atlanta, Georgia, 30331-2012, United States

  • Austin, Texas

    Austin, Texas, 78754-5122, United States

  • Bellflower, California

    Bellflower, California, 90706-7079, United States

  • Bentonville, Arkansas

    Bentonville, Arkansas, 72712-3873, United States

  • Berlin, New Jersey

    Berlin, New Jersey, 08009, United States

  • Budapest, Budapest

    Budapest, 1083, Hungary

  • Burgas, Burgas

    Burgas, 8000, Bulgaria

  • Charlotte, North Carolina

    Charlotte, North Carolina, 28211-4849, United States

  • Chicago, Illinois

    Chicago, Illinois, 60640-5017, United States

  • Chicago, Illinois

    Chicago, Illinois, 60641, United States

  • Győr, Győr-Moson-Sopron

    Győr, Győr-Moson-Sopron, 9024, Hungary

  • Homestead, Florida

    Homestead, Florida, 33032-8187, United States

  • Kalocsa, Bács-Kiskun

    Kalocsa, Bács-Kiskun county, 6300, Hungary

  • La Habra, California

    La Habra, California, 90631-3842, United States

  • Marlton, New Jersey

    Marlton, New Jersey, 08053, United States

  • Miami Lakes, Florida

    Miami Lakes, Florida, 33016-1553, United States

  • Miami Springs, Florida

    Miami Springs, Florida, 33166-7225, United States

  • Miami, Florida

    Miami, Florida, 33122-1335, United States

  • New Haven, Connecticut

    New Haven, Connecticut, 06519-1109, United States

  • Pleven, Pleven

    Pleven, 5800, Bulgaria

  • San Diego, California

    San Diego, California, 92103-2209, United States

  • Savannah, Georgia

    Savannah, Georgia, 31405-5701, United States

  • Sherman Oaks, California

    Sherman Oaks, California, 91403-1747, United States

  • Sofia, Sofia

    Sofia, 1282, Bulgaria

  • Sofia, Sofia-Grad

    Sofia, Sofia-Grad, 1431, Bulgaria

  • Torrance, California

    Torrance, California, 90504-4432, United States

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