Lumateperone for Major Depressive Disorder

"5 clinical studies are currently underway to study Lumateperone. Of these active trials, 5 have progressed to Phase 3 testing. The majority of research institutions studying Lumateperone are located in Little Rock, Arkansas; though, there are 153 total locations running trials for this medication."

"This clinical trial is admitting 470 individuals who are currently experiencing depression and falls within the ages of 18 to 65. Additionally, it is important that patients meet the following criteria: They must be male or female, between the ages of 18 to 65 years old inclusive; the start of the current major depressive episode (MDE) should be at least 8 weeks but not more than 18 months prior to Screening; they also must have at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline; has at least moderate severity of illness based on CGI-S score ≥ 4 at"

"According to the specific entrance requirements for this trial, anyone aged 18-65 is eligible to enroll."

"Lumateperone's safety is reflected by its Phase 3 status. This means that, while there is some efficacy data, there are multiple rounds of data supporting safety."

"That is correct. The information available on clinicaltrials.gov reveals that the trial is still enrolling patients. The trial was originally posted on 7/30/2021 and has had 15 different sites updated as of 4/7/2022. The goal is to have 470 people enrolled in the trial."

"Lumateperone has been under investigation since 2020 by Intra-Cellular Therapies, Inc. After the first Phase 3 study with 450 patients, the drug was approved. Currently, there are 5 active studies being conducted in 56 cities and 7 countries."