A study to evaluate the effect of xanomeline tartrate and trospium chloride on cognitive impairment in adults with schizophrenia.

1 1 1

What is this study about?

This study focuses on individuals living with Schizophrenia, a mental health disorder that can affect how a person thinks, feels, and behaves. A major aspect of this condition is cognitive impairment, which refers to difficulties with mental processes such as memory, attention, and problem-solving. The research aims to evaluate the effectiveness of a new medication called KarXT, which contains two active substances: xanomeline tartrate and trospium chloride. This medication is taken in the form of an oral capsule.

The purpose of the study is to determine if KarXT can improve mental functions in adults with this condition. During the study, participants will take different doses of the medication over a period of time. The process involves monitoring changes in mental abilities and other symptoms over 24 and 52 weeks to see how the treatment works over the long term.

Who Can Join the Study?

You must be between 18 and 55 years old.
You must be willing and able to agree to participate in the study after all the details have been explained to you. This includes being able to understand the informed consent, which is a formal document that explains all the risks and benefits of the study before you decide to join.
You must have a diagnosis of schizophrenia, which is a long-term mental health condition, that has been confirmed by a specific clinical interview called the MINI.
Your symptoms, as measured by specific medical rating scales called PANSS and G8/G10, must fall within a certain required range.
You must have been taking a stable dose of oral antipsychotic medication (pills used to manage symptoms of psychosis) for at least 4 weeks before the start of the study.
You must be taking only one type of antipsychotic medication, which is known as monotherapy, at the time of your first visit.
Your score on the SCIP, which is a test used to measure how much the condition affects your daily life, must be below 70.
If you are a female who is able to become pregnant, you must have a negative pregnancy test at the start of the study and must use a highly effective contraceptive method (a reliable way to prevent pregnancy) during the study and for 30 days after it ends.

Who Cannot Join the Study?

You are pregnant, breastfeeding, or have given birth within the last 3 months.
You currently meet the medical definitions for a manic episode (a period of extremely high energy or mood) or major depressive disorder (a period of severe sadness or low mood) as confirmed by a specific clinical interview.
You currently have a severe substance use disorder (addiction to drugs) or alcohol use disorder (addiction to alcohol) as confirmed by a clinical interview.
Your urine tests show the presence of phencyclidine, amphetamines, opiates (unless you have a valid prescription for short-term use), cocaine, or alcohol.
You have an intellectual disability (limitations in mental functioning), drug-induced psychosis (mental health symptoms caused by drug use), or a history of significant brain trauma (injury to the brain).
You are currently using, or have recently used, clozapine (a specific type of medication for mental health) for at least 6 weeks, or you use long-acting injectable antipsychotics (medications given by injection that last a long time), or anticholinergic treatment (medications that block certain nerve signals) that you cannot stop before the study starts.
You will need more than the allowed amount of psychotropic concomitant medication (other mental health medicines used alongside the study drug), such as high doses of benzodiazepines (medications used for anxiety or sleep), quetiapine (an antipsychotic), or antidepressants. Note that stable use of mood stabilizers (medications used to level out extreme moods) is allowed if the dose has been the same for at least 4 weeks.
You have a known allergy to xanomeline, trospium chloride, or any other ingredients in the study drug.
You have significant abnormal results from a physical examination, medical history review, ECG (a test that records the electrical activity of your heart), or laboratory tests.
You have participated in cognitive remediation (brain training programs) or completed the BACS (a specific test of brain function) within the last 4 weeks.
You have serious medical conditions affecting your cardiovascular (heart), pulmonary (lungs), renal (kidneys), hematologic (blood), gastrointestinal (stomach and intestines), endocrine (hormones), immunologic (immune system), dermatologic (skin), neurologic (nervous system), or oncologic (cancer) systems.
You have a history or high risk of urinary retention (difficulty emptying the bladder).
You have hepatic impairment (liver damage) of any level, or high levels of hepatic transaminases (liver enzymes that show liver stress) or bilirubin (a yellow substance in the blood) in your blood tests.
You have a history or high risk of narrow-angle glaucoma (a serious condition involving eye pressure).
You have active biliary disease (problems with the gallbladder or bile ducts, such as gallstones) or a history of bladder stones or frequent urinary tract infections.
For men, your serum prostate-specific antigen (a protein produced by the prostate) is higher than 10 ng/mL, or you have specific scores on the IPSS (a questionnaire used to check prostate health) that indicate prostate issues.
Your eGFR (a measure of how well your kidneys filter blood) is less than 60 mL/min, which indicates renal dysfunction (kidney problems).
You have a history of unstable hypertension (high blood pressure) or tachycardia (a heart rate that is too fast) at the time of the screening.
You are at a significant risk of suicide, defined as having active thoughts of suicide with an intent or a specific plan, as determined by a clinical assessment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy

Other Sites

Site Name	City	Country
Center for Neuropsychiatric Schizophrenia Research	Glostrup	Denmark
Virgen del Rocío University Hospital	Sevilla	Spain
Central Institute of Mental Health	Mannheim	Germany
National Institute of Mental Health	Klecany	Czechia
Semmelweis University	Budapest	Hungary
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Uanoomlonf Hlgkcwvg Cripjwy	Cologne	Germany
Bxfuffzmlcrafjc Sdvamiww Kz Amrpnaf dcc ofubuxhdnodp Rjaihj dza Boyfwmc Soapxugp	Augsburg	Germany
Asyxqgq Opxujkzbmzk Uoldircvcfwwh Cqxwquokxnhm Dhiup Seoxdr E Dmiay Siuljki Dx Tisult	Turin	Italy
Kjxvupgy dnn Uuntaiskslfs Muikbwdb Azs	Munich	Germany
Uwfsoflvlzrv Mcbbhwy Cyqontk Gyvfmkzfs	Groningen	The Netherlands
Frcmhnfcz Plit Ld Iddngpnxtmjxp Bktfxpgcc Dco Hegfsmtp Ulnnirsbltzuk Lv Pyw	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	01.01.2026
Belgium	Not yet recruiting	01.01.2026
Czechia	Not yet recruiting	01.01.2026
Denmark	Not yet recruiting	01.01.2026
Germany	Not yet recruiting	01.01.2026
Hungary	Not yet recruiting	01.01.2026
Italy	Not yet recruiting	01.01.2026
Spain	Not yet recruiting	01.01.2026
The Netherlands	Not yet recruiting	01.01.2026

Trial locations

Investigated drugs:

KarXT is an oral capsule being tested to see if it can help improve thinking, memory, and attention in adults with schizophrenia.

Schizophrenia – This is a mental disorder that affects how a person thinks, feels, and behaves. It often involves a disconnection from reality, which can cause people to see or hear things that are not there. Symptoms can include unusual beliefs or difficulty organizing thoughts and speech. Over time, it may also lead to a decrease in motivation or a reduction in social interaction. The condition can progress through different stages, impacting various aspects of daily functioning.

Trial ID:

2025-523060-20-00

Protocol code:

SHINE

NCT ID:

NCT07084831

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A study to evaluate the effect of xanomeline tartrate and trospium chloride on cognitive impairment in adults with schizophrenia.

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?