AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)

This research study is testing a new medicine called KarXT for teenagers affected by schizophrenia. Schizophrenia is a mental health condition that can cause a range of symptoms, including changes in thoughts, feelings, and behaviour. The study aims to find out if KarXT is an effective and safe treatment for young people aged 13 to 17. Participants will be split into groups; some will receive KarXT, and others will receive a placebo – a dummy medicine that looks the same but has no active ingredients. This helps researchers understand the true effect of KarXT. The main thing they'll be looking for is if KarXT helps improve symptoms after 5 weeks, and they will also check for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

20 Apr 2026

Schizophrenia

What is this study about?

This study is working to understand if a new medicine called KarXT can help teenagers (aged 13 to 17) who have schizophrenia. Schizophrenia is a brain disorder that affects how a person thinks, feels, and acts. It can make it hard to tell what's real and what's not, and can cause difficulties with daily life.

Researchers want to see if KarXT can reduce the symptoms of schizophrenia and if it's safe for young people to take. To do this, they will compare KarXT with a 'placebo' – which is a pill that looks and feels like KarXT but doesn't contain any active medicine. This helps them know for sure if any changes are due to KarXT itself and not something else. Because neither the patient nor the doctor will know who is getting which treatment, it helps keep the results fair and accurate.

The main goal is to check how much people's symptoms improve after 5 weeks using a special rating scale. They will also look at how this new medicine affects their overall condition. By doing this careful research, we hope to find new ways to help young people living with schizophrenia.

Key takeaways

New medicine KarXT is being tested for teenage schizophrenia.
Compares KarXT with a dummy medicine (placebo).
Focuses on improving symptoms and safety over 5 weeks.
Open to teenagers aged 13-17, both boys and girls.
Participation involves regular clinic visits for checks and questions.

Who may be eligible?

This study is specifically designed for teenagers between the ages of 13 and 17 who have been diagnosed with schizophrenia. Both boys and girls can take part in this research.

To be considered for the study, you would first need to have a medical evaluation by the study doctors. They will check your medical history and current health to make sure that taking part in the study is right for you and safe. There might be some specific health conditions or other medicines you're taking that would mean you couldn't join, but the doctors will explain all of this clearly.

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.

Are you between 13 and 17 years old?
Have you been diagnosed with schizophrenia?
Are you able to attend regular clinic visits?
Are you and your parent/guardian interested in learning more about new treatment options?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit where doctors would check if the study is a good fit for you. If you qualify, you would then begin the treatment phase. This involves regularly taking the study medicine (either KarXT or the placebo) for about 5 weeks. Throughout this time, you would have several visits to the clinic. During these visits, doctors and nurses would ask you questions about how you're feeling, your symptoms, and any side effects you might be experiencing. They would also likely do some checks, like taking your blood pressure or asking you to complete some questionnaires. After the 5-week treatment period, there would be a final follow-up visit to see how you are doing. The total time you would be actively involved in the study would be approximately 6-8 weeks.

Potential risks and benefits

Taking part in a study like this might have potential benefits; for example, you could receive a new medicine that might help your symptoms. However, there are also potential risks, such as experiencing side effects from the medicine, or the medicine might not work for you. The study doctors and nurses will explain all known side effects and answer any questions you have. It's important to remember that joining a study is always your choice, and you have the right to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania

Common questions

What is KarXT?

KarXT is a new medicine being tested to see if it can help with the symptoms of schizophrenia.

What is a 'placebo'?

A placebo is a dummy medicine that looks just like the real medicine but contains no active ingredients. It helps researchers understand the true effect of the new medicine.

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

No, neither you nor your doctor will know whether you are receiving KarXT or the placebo. This helps keep the study fair and accurate.

How long will I need to be in the study?

The active treatment and follow-up period for the study will last about 6 to 8 weeks in total.

Can I leave the study if I change my mind?

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