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RecruitingPhase 3

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

LB Pharmaceuticals Inc. · NCT07363577

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
456
US sites recruiting
13
Study start
March 25, 2026
Record last updated
July 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LB-102 (50 mg tablet); LB-102 (100 mg tablet); Placebo

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Pillar Clinical Research

    Bentonville, AR 72712

    Site contact: Fayz Hudefi, MD · 479-367-2688 · studies@pillarhc.com

  • Pillar Clinical Research

    Little Rock, AR 72204

    Site contact: Leslie Smith, MD · 501-307-1919 · studies@pillarhc.com

  • Woodland International Research Group

    Little Rock, AR 72211

    Site contact: Ashley Poole · 501-221-8681 · apoole@ergclinical.com

  • ProScience Research Group

    Culver City, CA 90230

    Site contact: Paola Aguirre · 424-227-8127 · paola.aguirre@proscienceerg.com

  • CenExel

    Garden Grove, CA 92845

    Site contact: Dakota Gainers · 714-943-5874 · d.gainers@cenexel.com

  • Synergy San Diego

    Lemon Grove, CA 92064

    Site contact: Corey Weise · 619-303-6130 · cweise@ergclinical.com

  • Clinical Innovations, Inc.

    Riverside, CA 92506

    Site contact: Evagelos Coskinas, MD, PhD · 866-236-3935 · info@CenExel.com

  • Health Synergy Clinical Research

    Boynton Beach, FL 33426

    Site contact: Katherine Grigelis · 561-473-3472 · kat@hscresearch.com

  • Innovative Clinical Research

    Miami Lakes, FL 33016

    Site contact: Melissa Rodco · 305-722-8444 · mrodco@segaltrials.com

  • Accelerated Clinical Trial

    Snellville, GA 30078

    Site contact: Alexis Melson · 978-255-1041 · amelson@acceleratedclinicaltrials.org

  • Pillar Clinical Research

    Chicago, IL 60641

    Site contact: Roueen Rafeyan, MD · 224-534-7332 · studies@pillarhc.com

  • Arch Clinical Trials

    St Louis, MO 63141

    Site contact: Israa Diab · 314-266-1243 · idiab@archclinicaltrials.com

  • Neuro-Behavioral Clinical Research

    North Canton, OH 44720

    Site contact: Crystal Blackford · 330-493-1118 · cblackford@nb-cr.com

Study contacts (from the official record)

  • Branislav Mancevski, MD · 212-605-0300 · clinicaltrials@lbpharma.us
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Study to Evaluate LB-102 for the Treatment of Adult Patients With… (NCT07363577) | Bored Studies