Table of Contents
- Clinical trials overview
- Major depressive disorder study
- Bipolar mania studies
- What the trials measure
- Who can take part
- How the studies are designed
Clinical trials overview
These clinical trials are studying Lumateperone in people with mood disorders.[1][2][2] 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.[1][2][2] All listed trials are Phase 3 studies, so they are testing the treatment in larger groups of patients.[1][2][2]
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.[1] This means their current antidepressant treatment has not worked well enough.[1] 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.[1]
The main result measure is the change in the MADRS total score from baseline to Day 43.[1] Baseline means the starting point before treatment begins.[1] MADRS is a depression rating scale used by clinicians to measure how severe depression symptoms are.[1] This study is authorised and plans to include 470 participants.[1]
Bipolar mania studies
Two trials are studying Lumateperone in patients with bipolar I disorder who are having manic episodes.[2][2] One of these studies also includes manic episodes with mixed features, which means signs of mania and depression happen together.[2] Both studies compare Lumateperone 42 mg taken by mouth once daily with placebo.[2][2]
The first bipolar mania study, 2024-513037-20-00, is completed and enrolled 374 participants.[2] The second, 2024-513036-26-00, is also completed and enrolled 350 participants.[2] Both studies are looking at the acute treatment of manic episodes, meaning treatment during a short, active phase of illness.[2][2]
What the trials measure
The depression study measures change in the MADRS total score from the start of the trial to Day 43.[1] The bipolar mania studies measure change in the YMRS total score from baseline to the end of Week 3.[2][2] YMRS is a scale used to rate mania symptoms such as high energy, unusual mood, and other signs of mania.[2][2]
These endpoints are the main outcomes the researchers use to see whether Lumateperone works better than placebo for the target condition.[1][2][2]
Who can take part
The depression trial is for patients with major depressive disorder who still have symptoms despite ongoing antidepressant therapy.[1] 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.[2][2]
- Depression study participants: people with major depressive disorder and an inadequate response to current antidepressant treatment.[1]
- Bipolar mania study participants: people with bipolar I disorder who are having manic episodes, with or without mixed features depending on the study.[2][2]
How the studies are designed
All three studies are interventional, which means the researchers give a treatment and then watch what happens.[1][2][2] Each trial includes a placebo group, so the study can compare Lumateperone with a treatment that looks the same but has no active medicine.[1][2][2] This kind of design helps researchers judge both benefit and safety in a fair way.[1][2][2]
