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Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Join a study on Lumateperone for pediatric bipolar depression treatment.

Recruiting
10-17 years
All
Phase 3

Study Overview: This research is testing a medicine called lumateperone for kids and teens aged 10 to 17 who have bipolar disorder and are feeling very sad, known as a major depressive episode (MDE). Bipolar disorder is a condition causing extreme mood swings. The study uses a method where neither the participants nor the researchers know who gets the actual medicine and who gets a fake pill, called a placebo, to ensure fairness. The study lasts for about 9 weeks.

  • Study Length: The study spans 9 weeks, including screening, treatment, and follow-up phases.
  • Visits and Treatment: Participants will visit the clinic several times and will either get the medicine or a placebo.
  • Risks and Monitoring: Safety is monitored closely, and a doctor will assess if the participant is safe to join the study.

Eligibility: Kids must have a diagnosis of bipolar disorder, have experienced mood swings before, and their current sad episode should last between 4 weeks and 12 months. They should not have other main mental issues except for ADHD, which must be stable if treated. Kids with recent suicidal behavior or risks are not included for safety reasons.

Study details
    Bipolar Depression

NCT06372964

Intra-Cellular Therapies, Inc.

12 October 2024

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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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