All studies
Not yet recruitingPHASE3INTERVENTIONAL

Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

This important study, called a Phase 3 clinical trial, is looking for people with schizophrenia to test a new medication called KarXT. The main goal is to find out if KarXT can help prevent the symptoms of schizophrenia from returning, or relapsing. Participants will either receive KarXT or a placebo (a dummy pill with no active medicine) to see how well it works and if it's safe. This type of research is crucial for developing new and better treatments to help people manage their condition. All participants will be closely monitored by a medical team.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Enrolment target
472
Start
03 Sep 2026
Estimated completion
03 Mar 2029

What is this study about?

This research study is focused on improving treatments for schizophrenia, a long-term mental health condition that affects how a person thinks, feels, and behaves. The study is particularly interested in preventing relapses, which is when symptoms return or get worse after a period of improvement. Preventing relapses is a major goal in managing schizophrenia, as it can significantly impact a person's life and well-being.

The new medicine being tested is called KarXT. Researchers want to compare it to a 'placebo', which is a treatment that looks like the real medicine but contains no active ingredients. This comparison helps scientists understand if KarXT is truly effective and safe. By taking part in such a study, you could contribute to medical knowledge and potentially help others with schizophrenia in the future.

This is a 'Phase 3' study, meaning it's one of the final steps before a new medicine might be considered for general use. These studies are vital for making sure new treatments are both safe and work well for a large number of people before they become widely available.

Key takeaways

  • This study evaluates KarXT, a new medicine for schizophrenia.
  • It aims to prevent symptoms from coming back (relapse prevention).
  • It's a Phase 3 study, a late stage before potential general use.
  • Participants will receive either KarXT or a placebo.
  • Close medical monitoring and regular visits are required.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and have been diagnosed with schizophrenia for at least a year. You should have had a hospital stay for schizophrenia sometime in the last year, and currently be experiencing some symptoms, but not severely unwell or in a first-time episode.

There are also some requirements about your current health, such as your body mass index (BMI). You cannot have other significant mental health conditions diagnosed recently, or be at risk of suicidal thoughts. If you've previously had trouble responding to schizophrenia medications or had very long hospital stays recently, you might not be suitable for this study.

The medical team will carefully check all these points to make sure the study is a good and safe fit for everyone involved. They will use specific questionnaires and assessments, like one called PANSS, to confirm you meet the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 65 years old?
  2. Have you been diagnosed with schizophrenia for at least a year?
  3. Have you been hospitalised for schizophrenia in the last year?
  4. Do you currently have some schizophrenia symptoms?
  5. Do you have a Body Mass Index (BMI) between 18 and 40?
  6. Have you not had a recent diagnosis of other major mental health conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either receive the new medicine, KarXT, or a placebo (a dummy pill). You won't know which one you're getting, and neither will your study doctor, until the study is over. You'll need to attend regular appointments at the study clinic where you'll have check-ups, assessments, and receive your study medication. These appointments will involve talking about your symptoms, having physical health checks, and possibly blood tests.

The medical team will closely monitor your health and any changes you experience throughout the study. The exact number of visits and the full duration of your participation will be fully explained to you before you make any decisions. There will also be follow-up calls or visits after you stop taking the study medication to see how you are doing.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new investigational treatment that might help your symptoms more effectively than current options, or simply getting very close medical attention during the study. However, there are also potential risks, like experiencing side effects from the medication or the assessments, or not receiving any benefit if you're on the placebo. You'll have a chance to discuss all potential risks and benefits in detail with the study team before agreeing to participate. Remember, your participation is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (61)

  • Local Institution - 0133
    Verified postcode
    Bentonville, United States
  • Local Institution - 0154
    Verified postcode
    Bentonville, United States
  • Local Institution - 0139
    Verified postcode
    Little Rock, United States
  • Local Institution - 0021
    Verified postcode
    Little Rock, United States
  • Local Institution - 0153
    Verified postcode
    Rogers, United States
  • Local Institution - 0190
    Verified postcode
    Anaheim, United States
  • Local Institution - 0040
    Verified postcode
    Bellflower, United States
  • Local Institution - 0188
    Verified postcode
    Chino, United States
  • Local Institution - 0032
    Verified postcode
    Culver City, United States
  • Local Institution - 0037
    Verified postcode
    Garden Grove, United States
  • Local Institution - 0068
    Verified postcode
    La Habra, United States
  • Local Institution - 0128
    Verified postcode
    Lemon Grove, United States

Common questions

What is KarXT?

KarXT is a new medicine being tested to see if it can help prevent symptoms of schizophrenia from returning.

What is a placebo?

A placebo is a 'dummy pill' that looks like the real medicine but doesn't contain any active ingredients. It's used to compare against the new medicine.

Will I know if I'm getting the real medicine?

No, neither you nor your study doctor will know if you're receiving KarXT or the placebo. This helps ensure the study results are fair and unbiased.

How long will I be in the study?

The full duration of your participation will be explained by the study team, including how long you'll take the medicine and how many follow-up visits there will be.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Relapse Prevention Trial Evaluating KarXT Treatment in Schiz…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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