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RecruitingPhase 3

Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia

A Randomized, Double-blinded, Placebo-controlled, Multicenter Study to Evaluate the Antipsychotic Efficacy and Safety of LB 102 in the Treatment of Adult Patients With Acute Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests LB-102 against a placebo, a pill with no active drug, in adults whose schizophrenia symptoms have recently gotten worse. It will look at how well LB-102 works, its safety, and its side effects.

This is a Phase 3, randomized, double blind, placebo controlled, fixed dose, study designed to evaluate the efficacy, safety, tolerability, and of LB-102 versus placebo for the treatment of adult patients with an acute exacerbation of schizophrenia.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Able to give informed consent, meaning you understand the study and agree to join.
  • Willing to stay in the hospital for the whole study.
  • Have schizophrenia based on standard diagnosis rules called DSM-5.
  • Have a body mass index (BMI), a measure of weight compared with height, from 18 to 40.
  • Have a score from 80 to 120 on PANSS, a scale that measures schizophrenia symptoms.

Who can't join

  • Are sexually active and unwilling to use highly effective birth control, or are breastfeeding.
  • Your PANSS symptom score rises by more than 20% between screening and the study's start.
  • Have a history of schizophrenia that did not respond to medicines, or have a DSM-5 diagnosis other than schizophrenia.
  • Are at risk of suicide or violent or destructive behavior.
  • Have unwanted body movements called tardive dyskinesia, with a score of 3 or higher on AIMS item 8 at screening; or restlessness called akathisia, with a BARS overall score of 3 or higher at screening.
  • Have diabetes that requires insulin.
  • Have known heart disease from poor blood flow, or a history of heart attack, heart failure, or procedures to open or bypass blocked heart arteries.
  • Have a serious disease or another condition that the study doctor thinks could make joining unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (13)

AR

CA

FL

GA

IL

MO

OH