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New hope for schizophrenia: phase 3 drug trial begins

NCT ID NCT07363577

Disease control Sponsor: LB Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times

Summary

This study tests a new drug, LB 102, to see if it helps reduce schizophrenia symptoms better than a placebo. About 456 adults with acute schizophrenia will take either the drug or a placebo for 6 weeks while staying in the hospital. The main goal is to measure changes in symptoms using a standard rating scale.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 456 people

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

Started

Mar 2026

Expected to finish

Oct 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: * Able to provide ICF * Willing to be hospitalized for duration of the study * Diagnosis of schizophrenia as defined by DSM-5 * BMI - 18-40 * PANSS 80-120 Exclusion Criteria: * Sexually active m/f not willing to adhere to highly effect birth control * Breast feeding * Increase in PANSS of \> 20% between screening and baseline * History of resistant treatment to schizophrenia medications * DSM-5 diagnosis other than schizophrenia * Risk of suicidal behavior * Risk of violent or destructive behavior * Clinically significant tardive dyskinesia determined by a score of ≥3 on Item 8 of the AIMS at Screening * Score of ≥3 on the BARS global clinical assessment of akathisia at Screening * Insulin dependent diabetes * Known ischemic heart disease or any history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the patient

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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

    13 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Accelerated Clinical Trial

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Arch Clinical Trials

    RECRUITING

    St Louis, Missouri, 63141, United States

  • CenExel

    RECRUITING

    Garden Grove, California, 92845, United States

  • Clinical Innovations, Inc.

    RECRUITING

    Riverside, California, 92506, United States

    Contact Email: •••••@•••••

  • Health Synergy Clinical Research

    RECRUITING

    Boynton Beach, Florida, 33426, United States

  • Innovative Clinical Research

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Neuro-Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Pillar Clinical Research

    RECRUITING

    Bentonville, Arkansas, 72712, United States

    Contact Email: •••••@•••••

  • Pillar Clinical Research

    RECRUITING

    Little Rock, Arkansas, 72204, United States

    Contact Email: •••••@•••••

  • Pillar Clinical Research

    RECRUITING

    Chicago, Illinois, 60641, United States

    Contact Email: •••••@•••••

  • ProScience Research Group

    RECRUITING

    Culver City, California, 90230, United States

  • Synergy San Diego

    RECRUITING

    Lemon Grove, California, 92064, United States

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

More trials for these conditions

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