Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Launched by INTRA-CELLULAR THERAPIES, INC. · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new long-acting injectable medication called lumateperone for patients with schizophrenia or schizoaffective disorder. The goal is to see how safe the medication is, how well patients tolerate it, and how the body processes it after a single injection. This trial is currently looking for participants who are clinically stable, meaning they haven't had any severe episodes of their condition for at least three months. Eligible participants must be between 18 and 55 years old, have a specific body weight and body mass index, and meet certain mental health criteria.

If you or someone you know is considering participating, they can expect to receive a single injection of the medication and will be monitored closely for any side effects or reactions. It's important to note that individuals with a history of certain psychiatric conditions, recent suicidal thoughts, or significant heart issues may not qualify for this study. Overall, this trial aims to gather important information that could help improve treatment options for those living with schizophrenia or schizoaffective disorder.

Gender

ALL

Eligibility criteria

• Main Inclusion Criteria:
• • Male or female patients between 18 and 55 years of age, inclusive;
• • Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
• • Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening;
• • Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1;
• • Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening.
• Main Exclusion Criteria:
• • History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
• • Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is a safety risk to him/herself or others;
• • Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables;
• • Has a QT interval corrected for heart rate using Fridericia formula \> 450 msec in males or \> 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.