This study focuses on Bipolar-I Disorder, specifically during periods of mania or mania with mixed features. During manic episodes, people may experience unusually high energy levels, reduced need for sleep, and potentially risky behavior. The study will test a medication called KarXT, which contains two active substances: trospium chloride and xanomeline tartrate. Some participants will receive KarXT capsules while others will receive a placebo.
The purpose of this research is to determine if KarXT is effective in reducing the severity and symptoms of mania in people with Bipolar-I Disorder. The study medication or placebo will be taken orally as capsules for a period of three weeks while participants are in the hospital. During this time, participants will not take other medications used to treat mental health conditions.
Throughout the study, healthcare providers will monitor participants’ symptoms and overall health. They will use various assessment tools to measure changes in manic symptoms and daily functioning. The study will also track any side effects that participants may experience during the treatment period.
Croatia 
Romania 
Slovakia 
Spain 
Sweden 
