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New pill aims to ease schizophrenia episodes

NCT ID NCT07467993

Symptom relief Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 2 times

Summary

This study tests an experimental oral drug called GXV813 in 142 hospitalized adults with schizophrenia. The goal is to see if it safely reduces symptoms like hallucinations and withdrawal during an acute episode. Participants are randomly assigned to receive GXV813 or a placebo, and neither they nor their doctors know which they get.

What this could mean

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

Active substance
GXV813 (an oral drug)
What this could lead to
If it works, this could point toward a new treatment option for acute schizophrenia episodes, helping reduce severe symptoms.
What could go wrong
This is an early Phase 2a trial with only 142 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are unknown.

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

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

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: 1. Participant is aged 18 to 65 years, inclusive, at screening 2. Participant is capable of providing informed consent 3. Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT) 4. Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements 5. Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening 1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms 2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening 6. Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items: i. Item 1 (P1; delusions) ii. Item 2 (P2; conceptual disorganization) iii. Item 3 (P3; hallucinatory behavior) iv. Item 6 (P6; suspiciousness/persecution) Exclusion Criteria: 1. Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening) 2. History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia 3. Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded 4. Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

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

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arch Clinical Trials LLC

    RECRUITING

    St Louis, Missouri, 63141, United States

  • CNRI Los Angeles LLC

    RECRUITING

    Pico Rivera, California, 90660, United States

  • CenExel iResearch

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Novartis Investigative Site

    RECRUITING

    Sofia, BGR, 1431, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Haskovo, 6300, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Kazanlak, 6100, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Lovech, 5500, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Sliven, 8800, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Sofia, 1377, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Veliko Tarnovo, 5000, Bulgaria

  • Novartis Investigative Site

    RECRUITING

    Vratsa, 3000, Bulgaria

  • Pillar Clinical Research LLC

    RECRUITING

    Bentonville, Arkansas, 72712, United States

  • Pillar Clinical Research LLC

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Segal Institute for Clinical Research

    RECRUITING

    Miami, Florida, 33016, United States

  • Uptown Research Institute LLC

    RECRUITING

    Chicago, Illinois, 60640, United States

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