RightFit
RecruitingPhase 3

52-week Open Label Safety-Tolerability Study

A 52 Week, Open Label Safety and Tolerability Study of LB-102 in Adult Patients With Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This 52-week study tests the long-term safety of LB-102 and how well people can tolerate it. It is for adults with stable schizophrenia, a mental illness that can affect thoughts and how people see reality. Everyone in the study knows which treatment they receive.

Phase 3, open label, multicenter study designed to assess the long term safety and tolerability of LB-102 for the treatment of adult patients with stable schizophrenia

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign an informed consent form to agree to take part.
  • Have stable schizophrenia, with a PANSS symptom score of 80 or less at screening.
  • Have a CGI-S illness severity score of 3 or less at screening.
  • Have stable physical health.
  • Have a body mass index (BMI) of 18 to 40, a measure based on height and weight.
  • Have taken antipsychotic medicine by mouth for at least 30 days.
  • Have a stable place to live.

Who can't join

  • Are sexually active and unwilling to use highly effective birth control.
  • Are breastfeeding.
  • Have a history of schizophrenia medicines not working well enough.
  • Currently have a mental health diagnosis other than schizophrenia under DSM-5 diagnostic rules.
  • Are at risk of suicidal behavior.
  • Have or have had a serious disease affecting the heart, lungs, liver, kidneys, blood, digestive system, hormones, immune system, skin, or nervous system, or cancer. The source's list of excluded diseases is cut off.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Provide ICF * Patients clinically stable PANSS \</= 80 at screening * CGI-S \</+ 3 at screening * Medically stable * BMI 18 -40 * Taking oral antipsychotic treatment for at least 30 days * Have stable living environment Exclusion Criteria: * Sexually active M/F patients not willing to use highly effective contraception * Breast feeding * History of treatment resistance to schizophrenia medications * DSM-5 current diagnosis other than schizophrenia * Risk of suicidal behavior * History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other

Study sites (23)

AR

AZ

CA

FL

GA

IL

MD

MO

NV

NY

OH

PA

TX