This study is about testing a new drug, Icalcaprant, to see if it's safe and works well for adults with bipolar disorder. Bipolar disorder is a condition where people have extreme mood changes. The study will involve about 195 adults from across the U.S.
Participants will take Icalcaprant or a placebo (a pill that doesn't have any medicine) once a day for 6 weeks. After that, there will be a follow-up for 4 weeks to check safety. A placebo is used to compare if the drug is really working. The study will have regular check-ups, blood tests, and questionnaires to see how the drug affects the participants.
- The study lasts for about 10 weeks, including the follow-up period.
- Participants will need to visit a hospital or clinic regularly for check-ups.
- There's a chance of experiencing more side effects compared to usual care.