Evaluating a new injectable medication for schizophrenia and schizoaffective disorder

A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder

This study is testing a new injectable medication for people with stable schizophrenia or schizoaffective disorder to see if it's safe and how well it works in their bodies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Intra-Cellular Therapies, Inc. (industry)
• Locations: 4 sites (Los Alamitos, California and 3 other locations)
• Trial ID: NCT06627413 on ClinicalTrials.gov

What this trial studies

This Phase 1b open-label study aims to assess the safety, tolerability, and pharmacokinetics of lumateperone long-acting injectable formulations in patients diagnosed with stable schizophrenia or schizoaffective disorder. Participants will receive a single intramuscular injection of the medication, and their responses will be monitored to determine how well the drug is tolerated and how it behaves in the body. The study focuses on individuals who have been stable and free from acute psychotic episodes for at least three months prior to screening.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 55 with a clinical diagnosis of schizophrenia or schizoaffective disorder who are clinically stable.

Not a fit: Patients with a history of other psychiatric conditions or recent suicidal ideation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-acting treatment option for patients with schizophrenia or schizoaffective disorder, potentially improving adherence and outcomes.

How similar studies have performed: While this approach is being explored in this specific formulation, similar long-acting injectable treatments have shown promise in managing schizophrenia in other studies.

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.

Where this trial is running

Los Alamitos, California and 3 other locations

• Clinical Site 2 — Los Alamitos, California, United States (RECRUITING)
• Clinical Site 3 — Atlanta, Georgia, United States (RECRUITING)
• Clinical Site 4 — Decatur, Georgia, United States (RECRUITING)
• Clinical Site 1 — Marlton, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: ITI Clinical Trials

Conditions: Schizophrenia or Schizoaffective