Mania – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Wed, 17 Jun 2026 04:02:46 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Mania – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A study testing xanomeline tartrate and trospium chloride added to current treatment for adults with bipolar I disorder experiencing mania https://clinicaltrials.eu/trial/a-study-testing-xanomeline-tartrate-and-trospium-chloride-added-to-current-treatment-for-adults-with-bipolar-i-disorder-experiencing-mania/ Wed, 29 Apr 2026 15:07:59 +0000 https://clinicaltrials.eu/trial/a-study-testing-xanomeline-tartrate-and-trospium-chloride-added-to-current-treatment-for-adults-with-bipolar-i-disorder-experiencing-mania/ This study is looking at Bipolar-I Disorder in people who are experiencing mania or mania with mixed features. Mania is a state where a person may feel extremely energetic, unusually happy or irritable, or have racing thoughts and difficulty sleeping. Mixed features means that symptoms of both mania and depression occur at the same time. The study will test a medication called KarXT, which is also known by the code name BMS-986510. This medication is a capsule that is taken by mouth and contains two active substances: xanomeline tartrate and trospium chloride. Some people in the study will receive KarXT while others will receive placebo. All people in the study will continue taking their current mood stabilizer medication, which will be either lithium, valproate, or lamotrigine.

The purpose of this study is to find out if KarXT added to a mood stabilizer works better than placebo added to a mood stabilizer in reducing the severity and symptoms of mania in people with Bipolar-I Disorder. The study will measure changes in mania symptoms and how well people are able to function in their daily lives. People taking part in this study will be those who are currently in the hospital because of a recent worsening of their manic symptoms that started within the past three weeks.

The study will last for five weeks. During this time, people will continue taking their regular mood stabilizer at the same dose they were taking before the study started, and they will also take either KarXT or placebo. The main measurement will look at how much manic symptoms have changed from the beginning to the end of the five-week period using a rating scale that evaluates manic symptoms. The study will also look at changes in overall functioning and severity of the condition.

]]> Long-term safety study of trospium chloride and xanomeline tartrate combination (KarXT) for treatment of manic episodes in adults with Bipolar I Disorder https://clinicaltrials.eu/trial/long-term-safety-study-of-trospium-chloride-and-xanomeline-tartrate-combination-karxt-for-treatment-of-manic-episodes-in-adults-with-bipolar-i-disorder/ Wed, 29 Apr 2026 15:07:10 +0000 https://clinicaltrials.eu/trial/long-term-safety-study-of-trospium-chloride-and-xanomeline-tartrate-combination-karxt-for-treatment-of-manic-episodes-in-adults-with-bipolar-i-disorder/ This study focuses on the long-term safety evaluation of KarXT in people with Bipolar-I Disorder who experience mania or mania with mixed features. Mania is a condition where a person experiences unusually high energy levels, reduced need for sleep, and sometimes impulsive or risky behavior. The medication being studied, KarXT, contains two active substances: trospium chloride and xanomeline tartrate, and is taken as oral capsules.

The purpose of this research is to determine if KarXT is safe and well-tolerated when used for an extended period by people with manic episodes related to Bipolar-I Disorder. The study will monitor how participants respond to the treatment over time and track any side effects that may occur during the treatment period.

During this open-label extension study, all participants will receive the study medication KarXT. The treatment period will last for approximately 51 weeks, during which participants will take the medication daily. Throughout the study, healthcare providers will regularly monitor participants’ health and well-being through various assessments and check-ups to ensure their safety.

]]> Study of trospium chloride and xanomeline tartrate (KarXT) for treating manic episodes in adults with bipolar I disorder https://clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-karxt-for-treating-manic-episodes-in-adults-with-bipolar-i-disorder/ Wed, 29 Apr 2026 15:07:09 +0000 https://clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-karxt-for-treating-manic-episodes-in-adults-with-bipolar-i-disorder/ 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.

]]> Study of trospium chloride and xanomeline tartrate (KarXT) for treatment of manic episodes in adults with bipolar I disorder https://clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-karxt-for-treatment-of-manic-episodes-in-adults-with-bipolar-i-disorder/ Wed, 29 Apr 2026 15:07:08 +0000 https://clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-karxt-for-treatment-of-manic-episodes-in-adults-with-bipolar-i-disorder/ This study focuses on people with Bipolar-I Disorder who are experiencing manic episodes. During manic episodes, people may feel extremely energetic, have racing thoughts, and engage in risky behaviors. The study will test a medication called KarXT, which contains two active substances: trospium chloride and xanomeline tartrate.

The purpose of this research is to determine if KarXT is effective in reducing the severity and symptoms of mania compared to placebo. The medication comes in the form of capsules that are taken by mouth. The study will involve patients who are hospitalized due to an acute manic episode.

During the study, participants will be randomly assigned to receive either KarXT capsules or placebo for a period of 3 weeks. Throughout this time, doctors will monitor changes in manic symptoms and overall mental health. The study will also track any side effects that may occur during the treatment period.

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