What Is Caplyta, and Why Does It Matter?
Caplyta (lumateperone) is a once-daily oral medicine now approved to be used with antidepressants to treat major depressive disorder (MDD) in adults. It belongs to a group of medicines called atypical antipsychotics. While experts don’t fully understand how it works, Caplyta is believed to help balance brain chemicals like serotonin and dopamine, which play a role in mood and emotions.
MDD is a serious and common mental health condition that affects how you feel, think, and function day to day. Around 22 million adults in the U.S. live with MDD. Many people don’t get full relief from antidepressants alone – about two-thirds still have symptoms even after treatment.
Caplyta gives another option for adults who haven’t had enough improvement with their current antidepressant.
Why Was It Approved?
Caplyta was approved based on two studies in adults with major depressive disorder (MDD) who didn’t get enough relief from antidepressants alone. In both studies, people who took Caplyta along with their antidepressant had more improvement in their depression symptoms than those who took a placebo with their antidepressant.
In one study, people taking Caplyta showed a bigger drop in their depression scores after six weeks, compared to those taking a placebo. Some people started feeling better as early as one to two weeks. More people taking Caplyta reached remission, meaning their symptoms became very mild or went away.
The most common side effects included dizziness, dry mouth, sleepiness, nausea, tiredness, and diarrhea. Serious side effects were rare, but they included movement problems, low white blood cell counts, and changes in blood pressure or heart rhythm. Unlike some other antipsychotic medicines, Caplyta did not cause significant weight gain or major changes in metabolism.
What Do I Need to Know?
Caplyta is taken once a day by mouth, with or without food.
You should not take Caplyta if you’re allergic to any of its ingredients. It’s not approved for children or for people with dementia-related psychosis. Caplyta may raise the risk of suicidal thoughts or actions in people under 25, especially when they're starting or changing the dose.
Tell your health care provider about all the medicines you take. Caplyta can interact with other drugs, especially those that affect liver enzymes like CYP3A4. If you have liver problems or take certain other medicines, your provider may need to adjust your dose.