AzTrials
AzTrials

SchizophreniaPhase 2NCT06179108

Randomized, Double-blinded, Placebo-controlled, Evaluating the Treatment With LB-102 in Patients With Acute Schizophrenia

A Phase 2 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 25 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
LB-102
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
359 participants
Where
25 sitesUnited States
Study dates
29 Nov 2023to 4 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A patient will be eligible for inclusion in the study if they meet all of the following criteria:
  • Patient who is able to provide written informed consent (as required by Institutional Review Board [IRB]) prior to the initiation of any protocol-required procedures.
  • Must be willing to be hospitalized for the duration of the inpatient period of the study.
  • Have stable living environment when not in a hospital.
  • Male and female patients 18 to 55 years of age inclusive at the time of informed consent with a diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by the MINI 7.0.2 .
  • Body mass index (BMI) must be ≥18 and ≤40 kg/m2.
Show all 14Show fewer
  • Patient who experiencing an acute exacerbation of psychotic symptoms, AND the patient requires hospitalization OR if already an inpatient at Screening, has been hospitalized for onset < 2 weeks for the current exacerbation.
  • Patients who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the Screening and Baseline visits:
  • Total PANSS score between 80 and 120, inclusive, and
  • Score of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items: Item 1 (P1; delusions), Item 2 (P2; conceptual disorganization), Item 3 (P3; hallucinatory behavior), Item 6 (P6; suspiciousness/persecution), and
  • CGI-S score ≥4 (moderately to severely ill).
  • Have received previous antipsychotic treatment (dose and duration as per the label) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the Investigator's opinion.
  • Have history of relapse and/or exacerbation of symptoms when they were not receiving antipsychotic treatment.
  • Patients willing to discontinue all prohibited psychotropic medications prior to Screening, if determined to be clinically appropriate by the Investigator, and not for the sole purpose of inclusion in the trial.

Who cannot join

  • A patient will be excluded from the study if they meet any of the following criteria:
  • Sex and Reproductive Status
  • Sexually active females of childbearing potential and male patients who are not practicing 2 different methods of birth control with their partner during the trial and for 30 days after the last dose of trial medication or who would not remain abstinent during the trial and for 30 days after the last dose.
  • Females who are breastfeeding or who have a positive pregnancy test result prior to receiving trial medication.
  • Patients who presented with a first episode of schizophrenia.
  • Improvement of ≥20% in total PANSS score between the Screening and Baseline assessments.
Show all 44Show fewer
  • History of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (dose and duration as per the label) or required clozapine within the last 12 months.
  • Current DSM-5 Axis I diagnosis other than schizophrenia.
  • Risk for suicidal behavior during the study.
  • Risk of violent or destructive behavior.
  • Patients with clinically significant tardive dyskinesia.
  • Patients with a score of 3 on the Barnes Akathisia Rating Scale (BARS) global clinical assessment of akathisia.
  • Patients who met DSM-5 criteria for substance abuse or dependence within the past 1 year.
  • Patients with hypothyroidism or hyperthyroidism or clinically significant abnormal thyroid function.
  • 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 subject or the validity of the study results.
  • Patients with insulin-dependent diabetes mellitus (i.e., any patient using insulin) are excluded. Patients with non-insulin-dependent diabetes mellitus may be eligible for the trial if their condition is stable as determined by satisfying ALL of the following criteria:
  • Glycosylated hemoglobin (HbA1c) <7.0%, and
  • Screening glucose must have been ≤125 mg/dL or ≤6.94 mmol/L (fasting) or <200 mg/dL or <11.1 mmol/L (nonfasting), and
  • Patient had been maintained on a stable regimen of oral antidiabetic medication(s) for at least 28 days prior to Screening or diabetes had been well controlled by diet for at least 28 days prior to Screening, and
  • Patient had no hospitalizations within the 12 months prior to Screening due to diabetes or complications related to diabetes, and
  • Patient's diabetes should not be newly diagnosed during Screening for the trial.
  • Patients with uncontrolled hypertension or symptomatic hypotension, or orthostatic hypotension
  • Patients with known ischemic heart disease or any history of myocardial infarction, congestive heart failure.
  • Patients with epilepsy or a history of seizures.
  • Patients with a positive urine drug screen or a positive blood alcohol test.
  • Patients with a history of alcohol use or substance use disorder (by DSM-5 criteria) within 12 months of Screening or a positive screen for drugs of abuse at Screening.
  • The following laboratory test results are exclusionary:
  • Platelets ≤75,000/µL or ≤75×109/L
  • Hemoglobin ≤9 g/dL or ≤90 g/L
  • Neutrophils, absolute ≤1000/µL or ≤1×109/L
  • AST and ALT >2 × upper limit of normal (ULN)
  • CPK >3 × ULN, unless discussed with and approved by the Medical Monitor
  • Creatinine ≥2 mg/dL or ≥176.8 µmol/L
  • Estimated creatinine clearance of <45 mL/min, calculated using the Cockcroft-Gault equation, at Screening
  • HbA1c ≥7.0%
  • Abnormal free T4 (during Screening), unless discussed with and approved by the Medical Monitor.
  • Clinically significant abnormal finding on the triplicate set of electrocardiograms (ECGs) or evidence of any of the following cardiac conduction abnormalities at Screening.
  • Patients who are currently taking oral antipsychotic medications, monoamine oxidase inhibitors (MAOIs), anticonvulsants (e.g., lamotrigine, Depakote), tricyclic antidepressants (e.g., imipramine, desipramine), selective serotonin reuptake inhibitors, and any other antidepressants or any other psychoactive medications (except lorazepam, zolpidem, zaleplon, eszopiclone, or similar benzodiazepines, diphenhydramine, benztropine, and propranolol). The medications should not be discontinued solely to make the patient eligible for enrollment in the study.
  • Patients who received electroconvulsive therapy, or Transcranial Magnetic Stimulation (TMS).
  • Patients with a history of neuroleptic malignant syndrome.
  • Patients with a history of allergic response
  • Prisoners or patients who were compulsorily detained (involuntarily hospitalized) for treatment of either a psychiatric or physical illness or have been in the last 6 months prior to the Screening Visit
  • Patients who have participated in another clinical study in which they received an experimental or investigational drug agent within 3 months of Screening.
  • -

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • CenExel ACMR

    Atlanta, Georgia, 30331

  • Community Clinical Research

    Austin, Texas, 78754

  • CelExel Clinical Innovations

    Bellflower, California, 90706

  • Pillar Clinical Research

    Bentonville, Arkansas, 72712

  • CenExel HRI

    Berlin, New Jersey, 08009

  • Synexus

    Cerritos, California, 90703

  • Uptown Research Institute

    Chicago, Illinois, 60640

  • Pillar Clinical Research

    Chicago, Illinois, 60641

  • ProScience Research Group

    Culver City, California, 90230

  • Midwest Clinical Research Center

    Dayton, Ohio, 45417

  • CenExel iResearch

    Decatur, Georgia, 30030

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • CenExel CBH

    Gaithersburg, Maryland, 20877

  • CelExel CNS

    Garden Grove, California, 92845

  • Behavioral Clinical Research, Inc.

    Hollywood, Florida, 33021

  • CenExel RCA

    Hollywood, Florida, 33024

  • Synergy Research

    Lemon Grove, California, 91945

  • Woodland Internation Research Group

    Little Rock, Arkansas, 72211

  • Segal Institute for Clinical Research

    Miami Lakes, Florida, 33016

  • Neuro-Behavioral Clinical Research

    North Canton, Ohio, 44720

  • Pillar Clinical Research

    Richardson, Texas, 75080

  • CenExel CIT Riverside

    Riverside, California, 92506

  • Woodland Research Northwest

    Rogers, Arkansas, 72758

  • NRC Research Institute

    Santa Ana, California, 92705

  • Richmond Behavioral Associates

    Staten Island, New York, 10314

Other trials in United States

About this study

Official title: 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 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to evaluate the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. To determine whether LB-102 administered to patients with acutely exacerbated schizophrenia demonstrates antipsychotic efficacy, as determined by a change from Baseline on the Positive and Negative Syndrome Scale (PANSS) total score, compared to placebo at 28 days. The secondary objectives of the study are to evaluate improvement in CGI-S, safety and tolerability, and pharmacokinetics.

Read the detailed description

This is a Phase 2, randomized, double-blind, placebo-controlled, multi-center inpatient study to examine the efficacy and safety of LB-102 in adult patients diagnosed with acutely exacerbated schizophrenia. The primary objective of the study is to assess the efficacy of LB-102 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores at day 28 in approximately 350 adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate improvement in CGI-S, PANSS subscale and Marder Factor scores, safety and tolerability, and pharmacokinetics in adult inpatients with a DSM-5 diagnosis of schizophrenia. The duration of treatment of the study is 28 days (4 weeks). Patients in this study will be randomized 3:3:3:1 to receive either: placebo, 50 mg QD LB-102, 75 mg QD LB-102, or 100 mg QD LB-102; that is, ~105 patients will get placebo, ~105 will get 50 mg LB-102 QD, ~105 will get 75 mg LB-102 QD, ~35 will get 100 mg LB-102 QD. LB-102 will be dosed orally once a day. Pharmacokinetic data will be measured for the first 60 patients in this study.

Conditions
Schizophrenia
Being tested
LB-102
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LB-102Drug

    LB-102 is a dopamine D2/3 and 5HT7 antagonist.

Study groups in NCT06179108
Study groupRoleWhat they receive
LB-102, 50 mg QDExperimentalOral LB-102: 50 mg (n ~ 105)
Receives: Drug: LB-102
LB-102, 75 mg QDExperimentalOral LB-102: 75 mg (n ~ 105)
Receives: Drug: LB-102
LB-102, 100 mgExperimentalOral LB-102: 100 mg (n ~ 35)
Receives: Drug: LB-102
Placebo comparatorPlacebo comparatorDrug: Placebo Matched placebo tablets
Receives: Drug: LB-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline to Week 4 in the PANSS Total Score

    The Positive and Negative Syndrome Scale (PANSS) is a scale used for measuring symptom severity of patients with schizophrenia. The PANSS rating is composed of 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Patients are scored from 1 to 7 on each symptom scale. The total score of the PANSS is a minimum of 30 and a maximum of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms whereas a higher PANSS total value represents a worse outcome

    Measured: Baseline to Day 28 (4 weeks)

Secondary outcomes (1)

  1. Change From Baseline to Week 4 in the CGI-S Score

    The Clinical Global Impressions-Severity (CGI-S) rates illness severity on a scale from 1 to 7 and has been shown to correlate with PANSS.

    The CGI-S is rated on a 7-point scale commonly used in clinical settings and research to evaluate the severity of symptoms and treatment responses in patients with mental disorders. The CGI-S specifically focuses on the severity of illness at the time of assessment, where clinicians assess the patient's current condition relative to their past. The scoring is for the CGI-S:1-normal, not at all ill, 2-Borderline mentally ill, 3-Mildly ill, 4-Moderately ill, 5-Markedly ill, 6-Severely ill, and 7-Extremely ill. The higher the score the more ill the patient is.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start29 Nov 2023
  3. Primary completion4 Dec 2024
  4. Study completion4 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized 3:3:3:1 to receive with placebo (n \~ 105), 50 mg LB-102 QD (n \~ 105), 75 mg LB-102 QD (n \~ 105), 100 mg LB-102 QD (n \~ 35) orally.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06179108
Sponsor's protocol ID
LB-102-003
Status last verified
Oct 2025
First submitted
12 Dec 2023
Last updated
22 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grattan V, Vaino AR, Prensky Z, Hixon MS. Antipsychotic Benzamides Amisulpride and LB-102 Display Polypharmacy as Racemates, S Enantiomers Engage Receptors D2 and D3, while R Enantiomers Engage 5-HT7. ACS Omega. 2019 Aug 15;4(9):14151-14154. doi: 10.1021/acsomega.9b02144. eCollection 2019 Aug 27.

    PubMed 31497735

  • Biernat L, Grattan VT, Hixon MS, Prensky Z, Vaino AR. A randomized, double-blind, placebo controlled, phase 1 study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of LB-102, a selective dopamine D2/3/5-HT7 inhibitor. Psychopharmacology (Berl). 2022 Sep;239(9):3009-3018. doi: 10.1007/s00213-022-06185-7. Epub 2022 Jul 16.

    PubMed 35841422

  • Eramo A, Correll CU, Walling DP, Kakar R, Bassani N, Callahan L, Lee BP, Prensky Z, Vaino AR, Kane JM. Antipsychotic Efficacy and Safety of LB-102 in the Treatment of Adults With Acute Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2026 Jul 1;83(7):682-693. doi: 10.1001/jamapsychiatry.2026.0428.

    PubMed 42018313

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LB-102 in people with Schizophrenia, run by LB Pharmaceuticals Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 in the PANSS Total Score (time frame: Baseline to Day 28 (4 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06179108, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in