Actively Recruiting
Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Led by LB Pharmaceuticals Inc. · Updated on 2026-05-06
456
Participants Needed
13
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Study to Evaluate LB-102 for the Treatment of Adult Patients With Acute Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- Willing to be hospitalized for the study duration
- Diagnosis of schizophrenia as defined by DSM-5
- Body mass index between 18 and 40
- Positive and Negative Syndrome Scale (PANSS) score between 80 and 120
You will not qualify if you...
- Sexually active male or female not willing to use highly effective birth control
- Breastfeeding
- Increase in PANSS score of more than 20% between screening and baseline
- History of resistance to schizophrenia treatments
- Diagnosis other than schizophrenia according to DSM-5
- Risk of suicidal behavior
- Risk of violent or destructive behavior
- Clinically significant tardive dyskinesia with a score of 3 or higher on Item 8 of the AIMS at screening
- Score of 3 or higher on the BARS global clinical assessment of akathisia at screening
- Insulin-dependent diabetes
- Known ischemic heart disease or history of heart attack, heart failure, angioplasty, stenting, or bypass surgery
- Significant cardiovascular, lung, liver, kidney, blood, digestive, hormone, immune, skin, nerve, or cancer conditions, or any other condition that could risk patient safety as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Pillar Clinical Research
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
Pillar Clinical Research
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
ProScience Research Group
Culver City, California, United States, 90230
Actively Recruiting
5
CenExel
Garden Grove, California, United States, 92845
Actively Recruiting
6
Synergy San Diego
Lemon Grove, California, United States, 92064
Actively Recruiting
7
Clinical Innovations, Inc.
Riverside, California, United States, 92506
Actively Recruiting
8
Health Synergy Clinical Research
Boynton Beach, Florida, United States, 33426
Actively Recruiting
9
Innovative Clinical Research
Miami Lakes, Florida, United States, 33016
Actively Recruiting
10
Accelerated Clinical Trial
Snellville, Georgia, United States, 30078
Actively Recruiting
11
Pillar Clinical Research
Chicago, Illinois, United States, 60641
Actively Recruiting
12
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Actively Recruiting
13
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
Research Team
A
Anna Eramo, MD
CONTACT
B
Branislav Mancevski, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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