NCT07363577
Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Recruiting
PHASE3Ages 18–65InterventionalTreatmentLB Pharmaceuticals Inc.
~456 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:LB-102 (50 mg tablet)LB-102 (100 mg tablet)Placebo
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to Week 6 on the Positive and Negative Syndrome Scale
Measured over 6 weeks
Conditions
Where it's being run
13 sites across 7 statesCalifornia4
Arkansas3
Florida2
Georgia1
Illinois1
Missouri1
Ohio1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Change from baseline to Week 6 on the Positive and Negative Syndrome Scale6 weeks
Determine whether LB-102, demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo: increase in scale indicates worsening while a decrease in the scale likely indicates a response to treatment