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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
M2m Med. Sp. z o.o.	Chorzow	Poland
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet	Budapest	Hungary

Other Sites

Site Name	City	Country
Instytut Psychiatrii I Neurologii	Warsaw	Poland
MBAL Dr. Ivan Seliminski – Sliven AD	Sliven	Bulgaria
Centrum Medyczne Hcp Sp. z o.o.	Poznan	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Semmelweis University	Budapest	Hungary
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
State Psychiatric Hospital Sv. Ivan Rilski – Novi Iskar	Novi Iskar	Bulgaria
Cqdxyr Fow Mchxps Hyesjz Pldke Dnk Izvt Tlfnah Bmpiqd Exqv	Burgas	Bulgaria
Nodi Pclfikgz Kbhoehu Paiunzkqxfpzxx Iaajzjizh	Tuszyn	Poland
Gbhnzmwpsworqovkw Vpnbuxxlv Puhn Abqugg Ecvoadyc Onvtpo Ktsflv	Gyor	Hungary
Ufyiyzfpzvkrrs Cmvmpls Kcxgogqup	Gdansk	Poland
Cituew Fjq Mtthwd Hdiexe Vvdeuo Euzv	Vratsa	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	15.09.2025
Hungary	Recruiting	15.09.2025
Poland	Recruiting	15.09.2025

Trial locations

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.

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 ID:

2024-520165-32-00

Protocol code:

CN012-0036

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?