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A study testing xanomeline tartrate and trospium chloride added to current treatment for adults with bipolar I disorder experiencing mania

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 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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting treatment period

    Upon joining the study, treatment will begin while taking the current mood stabilizer medication (lithium, valproate, or lamotrigine). The dose of this mood stabilizer will remain the same throughout the study.

    In addition to the mood stabilizer, either KarXT or a placebo will be assigned. KarXT contains xanomeline tartrate and trospium chloride as active substances. A placebo is a pill that looks identical but contains no active medicine.

    The assignment to receive either KarXT or placebo will be determined randomly, similar to flipping a coin. Neither the treating physician nor the participant will know which treatment has been assigned.

    KarXT or placebo will be provided in capsule form and will be taken by mouth.

  2. Step 2

    Treatment duration

    The treatment period will last for 5 weeks.

    During this time, the assigned capsules will be taken regularly according to the prescribed schedule.

    The mood stabilizer medication will continue to be taken at the same dose as before entering the study.

  3. Step 3

    Monitoring and assessments

    Throughout the 5-week treatment period, various assessments will be conducted to evaluate symptoms and overall condition.

    The Young Mania Rating Scale will be used to measure changes in manic symptoms. This scale evaluates symptoms such as elevated mood, increased activity, and sleep patterns.

    The Clinical Global Impression scale for Bipolar Disorder will be used to assess daily functioning and overall severity of the condition.

    These assessments will compare the condition at the beginning of treatment to the condition at Week 5.

  4. Step 4

    Completion of treatment period

    At the end of the 5-week treatment period, final assessments will be completed.

    The study treatment with KarXT or placebo will conclude at this point.

    Further instructions regarding continuation of the regular mood stabilizer medication will be provided by the treating physician.

Who can join the trial?

8 criteria

  • You must be between 18 and 65 years old at the time of signing the consent form
  • You must have a main diagnosis of Bipolar-I disorder, which is a mental health condition with episodes of extreme mood changes. This diagnosis must be confirmed through a detailed psychiatric evaluation and a structured interview
  • You must be currently experiencing a sudden worsening or return of a manic episode, which means a period of abnormally elevated mood, energy, or irritability. This episode may occur with or without mixed features, which means having symptoms of both mania and depression at the same time. This episode must have started within the last 3 weeks or less
  • You must need to stay in the hospital because of this sudden worsening or return of mania
  • Your body mass index must be between 18 and 40. Body mass index is a measure that uses your height and weight to estimate body fat
  • You must be currently taking a stable dose of one of these mood stabilizers: lithium, valproate, or lamotrigine. Mood stabilizers are medicines that help control mood swings. The dose must have stayed the same for at least 2 weeks before screening. If you are taking valproate, you must have been on this treatment for at least 7 months
  • Your score on the YMRS scale must be 18 or higher both at screening and at the start of the study. The YMRS is a rating scale that measures the severity of manic symptoms. Your score should not decrease by more than 20 percent between screening and the start of the study
  • Your score on the CGI-BP scale must be 4 or higher. This is a scale that measures how severe your bipolar disorder symptoms are overall

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
  • Without detailed exclusion criteria listed, it is not possible to identify which medical conditions, medications, or other factors would prevent someone from joining this clinical trial
  • Typically, exclusion criteria might include things like other serious medical conditions, certain medications that could interfere with the study drugs, pregnancy or plans to become pregnant, or allergies to the study medications, but these specific details are not provided in the available information
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Investigated drugs

  • KarXT

    is an investigational medication being studied as an add-on treatment for people with bipolar I disorder who are experiencing mania or mixed features. In this trial, it is being tested to see if it can help reduce the severity of manic symptoms when taken together with other mood stabilizing medications that participants are already taking.

  • Lithium

    is a mood stabilizer that is commonly used to treat bipolar disorder. It helps to control manic episodes and reduce mood swings. In this trial, some participants will continue taking lithium as their background treatment while also receiving either the study medication or placebo.

  • Valproate

    is a mood stabilizer medication used to treat manic episodes in people with bipolar disorder. It helps to control mood changes and reduce symptoms of mania. In this trial, some participants will continue taking valproate as their background treatment while also receiving either the study medication or placebo.

  • Lamotrigine

    is a mood stabilizer that is used to help prevent mood episodes in people with bipolar disorder. It can help reduce the occurrence of both manic and depressive episodes. In this trial, some participants will continue taking lamotrigine as their background treatment while also receiving either the study medication or placebo.

What is already known about the treatment

KarXT – KarXT is an investigational medication currently being studied in clinical trials and is not yet approved for general medical use. It is being tested as an add-on treatment taken by mouth in pill form, alongside standard mood stabilizers like lithium, valproate, or lamotrigine, for people experiencing manic episodes or mania with mixed features associated with Bipolar-I Disorder. The medication works at the molecular level by targeting specific receptors in the brain that help regulate mood and behavior, aiming to reduce the severity and symptoms of acute mania when combined with existing treatments.

Investigated diseases

Bipolar I Disorder – Bipolar I Disorder is a mental health condition characterized by extreme mood swings that include emotional highs called manic episodes. During a manic episode, a person may feel overly energetic, extremely happy, or unusually irritable. These manic periods can last for at least one week and significantly affect daily activities and relationships. Some people with Bipolar I Disorder may also experience mixed features, where symptoms of mania and depression occur at the same time. Between manic episodes, individuals may experience periods of normal mood or depressive episodes. The condition is a long-term illness that affects how a person thinks, feels, and behaves.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521845-26-00Protocol codeCN012-0046Estimated enrolment424 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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