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Can a new pill calm a schizophrenia Flare-Up? a trial seeks answers

NCT ID NCT07734493

Symptom relief Sponsor: Leal Therapeutics, Inc 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Sep 18, 2026 · Updated 10 times

Summary

This trial tests an experimental drug called LTX-001 in adults with schizophrenia who are experiencing a sudden worsening of symptoms. Participants stay in a research unit for about five weeks and receive either LTX-001 or a placebo. The main goal is to see if the drug is safe and tolerable, while also measuring how the body processes it and whether it shows any early signs of easing symptoms.

What this could mean

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

Active substance
an experimental drug called LTX-001
What this could lead to
If safe and effective, LTX-001 could offer a new treatment option for acute schizophrenia episodes.
What could go wrong
This is an early phase 1 trial with only 90 participants, focused on safety. It is too small and early to know if the drug actually improves symptoms.

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

About 90 people

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

Started

Aug 2026

Expected to finish

Mar 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 55 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: * BMI \> 17.5 and \< 38.0 kg/m2 and a total body weight \> 50.0 kg (110 lbs) * Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR) * Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study * PANSS total score ≥ 80 at the time of screening for the study * Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period * Sexually active adults must be willing to use an acceptable contraceptive method throughout the study Exclusion Criteria: * Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination * History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine * Current DSM-5-TR diagnosis other than schizophrenia * Pregnant or lactating female * Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening * Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening * Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Behavioral Clinical Research, Inc.

    RECRUITING

    Hollywood, Florida, 33021, United States

  • CBH Health LLC., dba CenExel Gaithersburg MD

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • CenExel Hollywood FL

    RECRUITING

    Hollywood, Florida, 33024, United States

  • CenExel iResearch, LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Hassman Research Institute, LLC

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Innovative Clinical Research, Inc.

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Pillar Clinical Research, LLC

    RECRUITING

    Little Rock, Arkansas, 72204, United States

    Contact Email: •••••@•••••

  • Pillar Clinical Research, LLC

    RECRUITING

    Richardson, Texas, 75080, United States

    Contact Email: •••••@•••••

  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit

    RECRUITING

    DeLand, Florida, 32720, United States

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