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Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder

Testing Lumateperone's safety for kids with schizophrenia or bipolar disorder.

Recruiting
10-17 years
All
Phase 3

This study checks if lumateperone, a medicine, is safe for kids with schizophrenia or bipolar disorder. The trial lasts 26 weeks and involves taking lumateperone daily. Kids aged 10-17 with diagnosed conditions can join. The study includes a 2-week screening to see if they qualify, a 26-week treatment period, and a 2-week follow-up after treatment ends.

Schizophrenia is a mental disorder affecting how a person thinks and feels, while bipolar disorder causes extreme mood swings. This study is open-label, meaning everyone knows what medication is being given. To join, the child’s parent or guardian must give permission, and the child must agree too.

  • The study lasts 26 weeks with regular clinic visits.
  • All participants receive the same medication daily.
  • Participants and their families must be aware of the potential risks, including mental health changes.

Children with other primary psychiatric disorders or those who pose a risk to themselves or others may not join. The study aims to ensure the medicine is safe and well-tolerated in young patients.

Study details
    Schizophrenia
    Bipolar Disorder

NCT06229210

Intra-Cellular Therapies, Inc.

12 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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