A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia

Summary

The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are: * how does the amount of the study drug in the body change over time (pharmacokinetics) * how does the study drug affect the symptoms of schizophrenia * how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics) Researchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments. After successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.

Detailed Description

After providing informed consent, eligible participants will be asked to visit the study site 3 times and stay overnight for 35 nights (up to 49 nights if up to 14 days of antipsychotic washout is applicable). Procedures will include: * A review of medical history and medications * Physical exams, including a neurologic (nervous system) assessment * Electrocardiograms (a measure of the heart's electrical activity) * Blood and urine collection * Psychiatric assessments including the Mini International Neuropsychiatric Exam (MINI), the Brief Assessment of Cognition in Schizophrenia (BACS), and the Positive and Negative Syndrome Scale (PANSS) * Overall assessment of status via the Clinical Global Impression Scale - Severity (CGI-S) * Assessment of extrapyramidal symptoms (EPS) as assessed by the Modified Simpson-Angus Scale (M-SAS), the Abnormal Involuntary Movement Scale (AIMS) and the Barnes Akathisia Rating scale (BARS) * Assessment of suicidality risk via the Columbia Suicidality Severity Rating Scale (C-SSRS) * Quantitative electroencephalography (qEEG) assessments * Ophthalmologic examinations * Administration of the study drug (or placebo) by mouth

Eligibility Criteria

Interventions