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

Exploring lumateperone for kids with schizophrenia or bipolar disorder.

Recruiting
10-17 years
All
Phase 3

This study is looking at how safe and easy a medicine called lumateperone is for kids aged 10 to 17 who have schizophrenia or bipolar disorder. Schizophrenia is a mental condition that can make people see or hear things that aren't there. Bipolar disorder is when someone has extreme mood swings, from very happy to very sad.

The study will last for 26 weeks. First, there's a 2-week screening period to check if participants can join. Then, during the open-label treatment period, everyone will take lumateperone once a day. After finishing the treatment, there’s a 2-week follow-up period to check on safety.

  • Participants need to visit the clinic multiple times during the study.
  • There might be some risks since it’s testing a medication.
  • No compensation is mentioned for joining the study.

Kids must get permission from a parent or guardian to join, and they must agree to be part of the study, too. They should not have other main mental health issues besides schizophrenia or bipolar disorder, and should not be at a high risk for self-harm. The study helps to understand how lumateperone works in younger people.

Study details
    Schizophrenia
    Bipolar Disorder

NCT06229210

Intra-Cellular Therapies, Inc.

12 October 2024

Step 1 Get in touch with the nearest study center
Entire USA
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FAQs

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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