This study tests lumateperone for treating bipolar mania, a condition where people have extremely high energy and mood swings. The study includes three phases:
- Screening Period: Lasts up to 1 week to see if you can join the study.
- Double-blind Treatment Period: Lasts 3 weeks, where you will get either lumateperone (42 mg) or a placebo (a pill with no medicine) without knowing which one.
- Safety Follow-up Period: Lasts 1 week to check on your health after treatment.
To join, you must be 18-75 years old, have bipolar I disorder with mania, and be hospitalized for mania. You cannot join if you have other serious mental health issues (like schizophrenia), are experiencing your first manic episode, or have a significant risk of suicide.
- **Study Length:** About 5 weeks (including screening and follow-up).
- **Visits Needed:** Multiple clinic visits for assessments and follow-up.
- **Risks/Compensation:** Possible side effects from treatment; compensation details not specified.
How understandable was the trial content above?
Hard to understand
Easy to understand