Bipolar I disorder – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 19 Jun 2026 04:03:25 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Bipolar I disorder – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A study to evaluate the safety and effectiveness of azetukalner in patients with bipolar depression https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-azetukalner-in-patients-with-bipolar-depression/ Thu, 30 Apr 2026 13:08:57 +0000 https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-azetukalner-in-patients-with-bipolar-depression/ This study focuses on individuals experiencing Bipolar Depression, which refers to periods of intense sadness or low mood that occur as part of Bipolar Disorder. This condition is characterized by shifts in mood, energy, and activity levels. The research aims to assess the safety and how well a person can tolerate a long-term treatment using the medication azetukalner, which is provided in the form of a 20 mg oral capsule.

During the study, participants will take one dose of XPF-010 every day. The process involves monitoring how the body reacts to the medication over an extended period to ensure it is safe for continued use. The study is open-label, meaning that both the researchers and the participants will know which medication is being administered.

]]> A study to evaluate the effectiveness and safety of azetukalner in patients experiencing depressive episodes associated with bipolar disorder. https://clinicaltrials.eu/trial/a-study-to-evaluate-the-effectiveness-and-safety-of-azetukalner-in-patients-experiencing-depressive-episodes-associated-with-bipolar-disorder/ Wed, 29 Apr 2026 15:09:24 +0000 https://clinicaltrials.eu/trial/a-study-to-evaluate-the-effectiveness-and-safety-of-azetukalner-in-patients-experiencing-depressive-episodes-associated-with-bipolar-disorder/ This study focuses on individuals experiencing Bipolar Depression, which refers to periods of intense sadness or low mood that occur in people diagnosed with Bipolar I Disorder or Bipolar II Disorder. These conditions involve significant shifts in mood, energy, and activity levels. The purpose of the study is to evaluate the effectiveness and safety of a medication called azetukalner, also known by its code name XPF-010, in treating these depressive periods.

Participants in the study will be assigned to receive either a 20 mg oral capsule of azetukalner or a placebo. The study uses a double-blind method, meaning neither the participants nor the researchers know which treatment is being administered at any given time. This approach helps ensure that the results are not influenced by expectations. During the course of the study, participants will take the assigned capsule once daily.

]]> 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.

]]> Study on the Effectiveness and Safety of Endoxifen for Adults with Bipolar I Disorder Experiencing Acute Mania or Manic Episodes https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-endoxifen-for-adults-with-bipolar-i-disorder-experiencing-acute-mania-or-manic-episodes/ Wed, 29 Apr 2026 14:22:41 +0000 https://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-endoxifen-for-adults-with-bipolar-i-disorder-experiencing-acute-mania-or-manic-episodes/ This clinical trial is focused on studying the effects of a medication called Endoxifen in patients with Bipolar I Disorder. Bipolar I Disorder is a mental health condition characterized by extreme mood swings, including episodes of mania, which is a state of high energy and activity. The study aims to evaluate how effective and safe Endoxifen is in treating adults experiencing acute manic episodes, which may or may not include mixed features, such as symptoms of both mania and depression.

Participants in the study will receive either Endoxifen or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be “double-blind,” meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of 21 days, during which participants will take the medication orally in the form of tablets.

The main goal of the study is to observe changes in the severity of manic symptoms from the beginning to the end of the study period. This will be measured using a scale called the Young Mania Rating Scale (YMRS), which helps assess the severity of manic episodes. Additionally, the study will look at other factors, such as overall improvement in mood and any changes in depression symptoms. The results will help determine if Endoxifen is more effective than the placebo in managing symptoms of Bipolar I Disorder during acute manic episodes.

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