The U.S. Food and Drug Administration (FDA) has approved a new use for a medicine called Caplyta, also known by its scientific name lumateperone.
This drug can now be used along with traditional antidepressants to help adults who suffer from major depressive disorder, also known as depression.
This is an important step because many people with depression do not fully get better with standard antidepressants alone.
Caplyta was already approved for treating bipolar depression—both type I and type II—and for schizophrenia in adults. With this new approval, Caplyta becomes the only drug approved by the FDA for bipolar depression as both a single treatment and a combination treatment.
Now, it is also approved as an added treatment for people with regular depression who are already taking antidepressants but still have symptoms.
The FDA’s decision was based on the results of two large clinical studies, known as study 501 and study 502. These studies involved people with major depression who were already taking antidepressants.
In both studies, researchers added either Caplyta or a placebo (a fake pill) to the patients’ current treatment. They then watched closely to see how symptoms of depression changed over time.
Researchers used two common tools to measure depression symptoms: the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression Scale-Severity index (CGI-S). These tools allow doctors to track how much a person’s mood, energy, sleep, and daily functioning improve over several weeks.
The results were clear and promising. In both studies, people who took Caplyta along with their antidepressants had a bigger drop in their depression scores than those who took the placebo. In study 501, improvements were noticeable as early as the first week.
In study 502, improvements started showing by the second week. After six weeks, both groups using Caplyta had significantly better scores on both depression rating tools compared to the placebo group.
This early improvement is important because people with depression often wait many weeks to see if a medication is working. Caplyta seems to work faster when added to regular treatment. Faster relief may reduce suffering and even prevent worsening of symptoms.
Dr. Roger McIntyre from the University of Toronto, one of the researchers involved, noted that depression is a complex and varied condition. What works for one person may not work for another. That’s why having more treatment options is important.
Dr. McIntyre explained that adding Caplyta could help those who are still struggling with symptoms while on an antidepressant. In some cases, this added treatment might help patients reach remission, meaning their symptoms go away almost completely—which is the main goal of treating depression.
Looking at the study findings, it is clear that Caplyta offers a meaningful benefit for people with difficult-to-treat depression. The improvements in mood and functioning were not only seen in numbers but also considered clinically important.
This means that the changes likely made a real difference in patients’ daily lives. The fact that benefits showed up quickly—within one or two weeks—gives hope to patients and doctors who are looking for faster relief from this serious condition.
While every medicine can have side effects and should be discussed with a doctor, this approval gives patients and healthcare providers a new tool to fight depression more effectively. As more research continues, treatments like Caplyta may offer better paths toward recovery and well-being.
If you care about health, please read studies that scientists find a core feature of depression and this metal in the brain strongly linked to depression.
For more health information, please see recent studies about drug for mental health that may harm the brain, and results showing this therapy more effective than ketamine in treating severe depression.
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