In short
Clinical trials are studying Lumateperone in people with major depressive disorder and bipolar I disorder with mania. These studies look at whether Lumateperone is safe and whether it helps improve symptoms compared with placebo. The trials include adults with depression that has not responded well enough to current antidepressant treatment and people with manic episodes.
Key points
- Clinical trials of Lumateperone are focused on two main conditions: major depressive disorder and bipolar I disorder with mania. All listed studies are Phase 3 trials, which means they are testing the treatment in larger patient groups. The depression study looks at people who still have symptoms despite ongoing antidepressant therapy. The bipolar studies look at patients with manic episodes, including some with mixed features. The main results being measured are changes in MADRS for depression and YMRS for mania. All of the trials compare Lumateperone with placebo.
Clinical trials overview
These clinical trials are studying Lumateperone in people with mood disorders. The studies are looking at whether it helps with symptoms and whether it is safe when compared with placebo, which is a look-alike treatment with no active substance. All listed trials are Phase 3 studies, so they are testing the treatment in larger groups of patients.
Major depressive disorder study
One trial, NCT05850689, is studying Lumateperone in patients with major depressive disorder who have had an inadequate response to ongoing antidepressant therapy. This means their current antidepressant treatment has not worked well enough. The study tests Lumateperone 42 mg taken by mouth once daily as an add-on treatment, also called adjunctive treatment, meaning it is added to the patient’s existing antidepressant medicine.
The main result measure is the change in the MADRS total score from baseline to Day 43. Baseline means the starting point before treatment begins. MADRS is a depression rating scale used by clinicians to measure how severe depression symptoms are. This study is authorised and plans to include 470 participants.
Bipolar mania studies
Two trials are studying Lumateperone in patients with bipolar I disorder who are having manic episodes. One of these studies also includes manic episodes with mixed features, which means signs of mania and depression happen together. Both studies compare Lumateperone 42 mg taken by mouth once daily with placebo.
The first bipolar mania study, 2024-513037-20-00, is completed and enrolled 374 participants. The second, 2024-513036-26-00, is also completed and enrolled 350 participants. Both studies are looking at the acute treatment of manic episodes, meaning treatment during a short, active phase of illness.
What the trials measure
The depression study measures change in the MADRS total score from the start of the trial to Day 43. The bipolar mania studies measure change in the YMRS total score from baseline to the end of Week 3. YMRS is a scale used to rate mania symptoms such as high energy, unusual mood, and other signs of mania.
These endpoints are the main outcomes the researchers use to see whether Lumateperone works better than placebo for the target condition.
Who can take part
The depression trial is for patients with major depressive disorder who still have symptoms despite ongoing antidepressant therapy. The bipolar trials are for patients with bipolar I disorder who are experiencing manic episodes, with one study also including manic episodes with mixed features.
- Depression study participants: people with major depressive disorder and an inadequate response to current antidepressant treatment.
- Bipolar mania study participants: people with bipolar I disorder who are having manic episodes, with or without mixed features depending on the study.
How the studies are designed
All three studies are interventional, which means the researchers give a treatment and then watch what happens. Each trial includes a placebo group, so the study can compare Lumateperone with a treatment that looks the same but has no active medicine. This kind of design helps researchers judge both benefit and safety in a fair way.