Tests LB-102 tablets in adults with acute schizophrenia
Tests LB-102 tablets against placebo in adults during acute schizophrenia flare-ups.
Plain-language title generated from the registry record
Registry title: Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Key facts
- Where
- Bentonville, Boynton Beach, Chicago, Culver City, Garden Grove, Lemon Grove, Little Rock, Miami Lakes, North Canton, Riverside, Snellville, and St Louis, United StatesSee the 13 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07363577, who can take part
Where in United States
- Pillar Clinical ResearchBentonville, United StatesTaking people
- Health Synergy Clinical ResearchBoynton Beach, United StatesTaking people
- Pillar Clinical ResearchChicago, United StatesTaking people
- ProScience Research GroupCulver City, United StatesTaking people
- CenExelGarden Grove, United StatesTaking people
- Synergy San DiegoLemon Grove, United StatesTaking people
- Pillar Clinical ResearchLittle Rock, United StatesTaking people
- Woodland International Research GroupLittle Rock, United StatesTaking people
- Innovative Clinical ResearchMiami Lakes, United StatesTaking people
- Neuro-Behavioral Clinical ResearchNorth Canton, United StatesTaking people
- Clinical Innovations, Inc.Riverside, United StatesTaking people
- Accelerated Clinical TrialSnellville, United StatesTaking people
- Arch Clinical TrialsSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- LB Pharmaceuticals Inc.
- Trial code
- NCT07363577
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
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: History of resistant treatment to schizophrenia medications; 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; Sexually active m/f not willing to adhere to highly effect birth control; Breast feeding; Increase in PANSS of > 20% between screening and baseline; 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.