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Study of trospium chloride and xanomeline tartrate (KarXT) for treatment of manic episodes in adults with bipolar I disorder

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be confirmed through a comprehensive psychiatric evaluation

    You must be between 18 and 65 years old

    You must have a diagnosis of Bipolar-I disorder

    You must be experiencing an acute manic episode lasting 3 weeks or less

    You will need to be hospitalized due to acute mania symptoms

    Your Young Mania Rating Scale (YMRS) score must be 20 or higher

  2. Step 2

    Medication discontinuation

    Any current psychiatric medications will need to be stopped

    The medication discontinuation period will last up to 14 days before starting the study drug

  3. Step 3

    Treatment period begins

    You will receive either KarXT capsules or placebo capsules (inactive pills)

    The medication will be taken by mouth

    Neither you nor your doctor will know which treatment you are receiving

  4. Step 4

    Monitoring period

    The study will last for 3 weeks

    Your manic symptoms will be evaluated using the Young Mania Rating Scale (YMRS)

    Your daily functioning will be assessed using a clinical rating scale

    You will be monitored for any side effects during the treatment period

  5. Step 5

    Final evaluation

    At week 3, final assessments will be conducted to measure changes in your symptoms

    Your overall health status will be evaluated

    The study will conclude after the final assessment

Who can join the trial?

8 criteria

  • You must be between 18 and 65 years old when signing the consent form
  • You must have been diagnosed with Bipolar-I disorder (a mental health condition that causes extreme mood swings) confirmed by a detailed psychiatric evaluation
  • You must be currently experiencing an acute episode of mania (a period of extremely elevated mood, energy and activity) or mania with mixed features that started within the last 3 weeks
  • You must need hospital admission due to your current manic episode
  • You must be able to stop taking all your current psychiatric medications for up to 14 days before starting the study medication
  • Your score on the Young Mania Rating Scale (a test that measures manic symptoms) must be 20 or higher both during initial screening and when starting the study
  • Your score on the Clinical Global Impressions-Bipolar scale (a test that measures illness severity) must be 4 or higher both during initial screening and when starting the study
  • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • Current diagnosis of any psychiatric disorder other than Bipolar I Disorder
  • History of substance abuse or dependence within the past 3 months (except nicotine or caffeine)
  • Significant medical conditions that could affect study participation or patient safety
  • Pregnant or breastfeeding women
  • Use of medications that could interact with the study drug
  • History of severe allergic reactions to medications
  • Participation in another clinical trial within the past 30 days
  • Unable to provide informed consent
  • History of not following medical treatment plans
  • Unstable living situation that could interfere with study visits
  • Recent changes in regular psychiatric medications
  • History of severe heart, liver, or kidney problems
  • Current thoughts of self-harm or suicide
  • History of not responding to similar psychiatric medications
  • Unable to attend regular study visits
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Investigated drugs

KarXT is an investigational medication being studied for treating manic episodes in people with Bipolar I Disorder. It is designed to help reduce the severity and symptoms of mania. This medication works differently from existing treatments for bipolar disorder, though its exact mechanism of action in treating manic episodes is being evaluated in this clinical trial.

What is already known about the treatment

KarXT - An investigational medication administered orally that is currently being studied in Phase 3 clinical trials for the treatment of manic episodes in Bipolar I Disorder. This novel therapeutic agent combines xanomeline (a muscarinic receptor agonist) with trospium (a muscarinic receptor antagonist) to target the cholinergic system in the brain while minimizing peripheral side effects. The medication is being evaluated for its potential to reduce the severity and symptoms of mania in patients with Bipolar I Disorder, representing a new approach to treating acute manic episodes with a different mechanism of action compared to current standard treatments.

Investigated diseases

Bipolar I Disorder with Mania - A mental health condition characterized by episodes of extreme mood elevation known as mania. During manic episodes, individuals experience unusually high energy levels, reduced need for sleep, racing thoughts, and increased activity levels. Some people may also experience mixed features, where symptoms of mania occur alongside symptoms of depression simultaneously. Manic episodes typically last at least a week and can significantly affect daily functioning, relationships, and decision-making abilities. The condition involves changes in behavior, such as talking faster than usual, taking on multiple activities at once, and sometimes engaging in risky behaviors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520165-32-00Protocol codeCN012-0036Estimated enrolment274 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).