This study tests the medicine lumateperone for treating adults with bipolar I disorder, which can cause strong mood swings and mania (very high energy and activity levels). Participants must be aged 18 to 75 and already in a hospital due to a manic episode. The study involves three phases: a screening period of up to one week to check if participants qualify, a three-week treatment period where they get either lumateperone or a placebo (a fake pill with no medicine) without knowing which one they are getting, and a one-week follow-up to ensure safety.
Key Points:
- Study Length: Total of 5 weeks, including screening, treatment, and follow-up.
- Treatment: Participants will receive either lumateperone or a placebo for 3 weeks.
- Eligibility: Must have a diagnosis of bipolar I disorder, be hospitalized for a manic episode, and meet other health criteria.
Participants with other major mental health conditions or those at risk of harming themselves or others cannot join. This study helps researchers understand how well lumateperone works for bipolar mania.