Research Center: Perceptive Pharma Research LLC
Location: Richmond, Texas, USA
IRB/HREC: This study has been reviewed by an independent Institutional Review Board (IRB)/Ethics Committee (EC), which protects the rights, safety, and well-being of study participants.

Caring for a child with bipolar depression can feel like carrying a weight no family should bear alone. The ups and downs, the uncertainty, the worry, it’s a lot to hold.

This study is exploring an investigational study drug to see if it can make a real difference for individuals aged 10 to 17. Families who participate join a wider effort to find safer, more effective care for kids and teens living with bipolar disorder. It’s about creating a path toward more support, stability, and peace of mind.

Interested? Join this new research study.

• Participants will receive study-related care, including the study drug or placebo, at no cost. Each teen will have an equal chance of receiving either the study drug or the placebo. Neither you, your child, nor the study doctor will know which one your child is receiving during the study.
• Participants will be closely monitored by medical professionals throughout the study.
• Participants may be compensated for time and travel. Compensation will only be provided to eligible participants who complete the study.
• Some participants may experience improvements in their bipolar depression symptoms.
• Families will play an important role in research that could lead to safer and more effective treatment options for young people living with bipolar disorder.
• By taking part, families can contribute to a global effort to better understand and treat pediatric bipolar depression.

• Your child will receive a detailed outline of all details of the study, including treatment, risks, and procedures, and you will be given the chance to ask study staff questions before you decide whether to participate.
• If you decide to have your child participate in the study and later feel that they no longer wish to be part of it, they can withdraw at any time
• Your child’s records relating to this study and any other information received will be kept strictly confidential, except as required by the law.

Eligible:

• Individuals ages 10 to 17 with a diagnosis of bipolar I or bipolar II disorder who are currently experiencing a depressive episode.
• Must have had at least one manic or hypomanic episode in the past (confirmed by family, caregiver, or medical records).
• The current depressive episode must have lasted at least 4 weeks but less than 12 months.
• Must be an outpatient (living at home, not in a hospital) during the study, except for a short inpatient stay during screening if needed.
• Must be able to swallow capsules.
• Must be able to attend the research center for 9 study visits over approximately 2 months.

Ineligible:

• Those with another main psychiatric condition (such as schizophrenia). Exception: ADHD is allowed if treatment has been stable for at least 30 days.
• Those who were hospitalized for a manic episode in the past 30 days.
• Those who have recently received treatments such as ECT (electroconvulsive therapy), vagal nerve stimulation, or TMS (magnetic stimulation) in the past 6 months.
• Those with known allergies or sensitivities to lumateperone or similar medicines.
• Those currently taking clozapine, certain sleep medications, or who have been recently treated with long-acting injectable antipsychotics.
• Those who have taken part in more than 2 clinical studies for brain-related conditions in the last 3 years.
• Those with certain medical conditions, including HIV, chromosomal disorders (such as Down syndrome), seizure history (except febrile seizures), brain tumors, or significant head trauma.
• Children of study staff or site employees.

The study team will explain the research in its entirety, but some details include:

• Participants will be asked to complete health checks and lab tests, including physical exams, vital signs, blood work, ECGs, and screenings for conditions like thyroid, diabetes, and hepatitis.
• Participants will be asked to take part in mental health assessments, such as interviews, questionnaires, and rating scales that measure mood, behavior, and quality of life.
• Participants will be asked to follow study procedures for the study drug, including receiving the study drug (or placebo), returning unused study drug, and reporting any side effects.

Perceptive Pharma Research LLC
Perceptive Pharma Research LLC is a clinical research company formally established in 2016 with locations in Richmond, TX, and Katy, TX. Their team of highly trained professionals is committed to seeing you improve.