Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intra-Cellular Therapies, Inc.
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients aged 18 to 50 years, inclusive
Clinical diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening per Investigator assessment
On a stable dose of antipsychotic medication, including lumateperone, for at least 3 months prior to the Screening Visit
Clinical Global Impression - Severity (CGI-S) score ≤ 3
You may not be if
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
History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study
Any suicidal ideation within the 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening 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
Surgical or medical condition (active or chronic) that in the Investigator's opinion may interfere with drug absorption, distribution, metabolism, or excretion of the study drug or any other condition that may place the patient at risk; history of gastric bypass or sleeve gastrectomy; history of severe dystonic reaction on antipsychotics such as laryngeal spasm
Clareo Health | Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
