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. 

Who Can Participate:

• Young people ages 10 to 17 who are experiencing ongoing mood-related symptoms, including depressive symptoms, and periods of unusually elevated or irritable mood
• Has experienced at least one period where their mood or energy was much higher than usual (for example: needing less sleep, talking more than usual, racing thoughts, or impulsive behavior)
• Has been experiencing depressive symptoms (such as sadness, irritability, low energy, or loss of interest) for 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.

Who Cannot Participate:

• 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.

• 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.
• Your child’s safety comes first, with close monitoring and regular check-ins from an experienced study team.
• Parents or caregivers play an active role and can ask questions or raise concerns at any time.
• 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.

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.

Research Site:

Perceptive Pharma Research LLC

Location:

Richmond, Texas, USA

Ethics Committee:

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.

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.

Qualified health professionals will monitor your health as it relates to the study.

This trial has been reviewed and approved by an independent ethics committee. 

All research staff that are running this trial have been trained in GCP, which assures that the rights, safety, and well-being of research subjects are protected and respected.

We follow all established national privacy standards used in all doctors' offices, hospitals and other businesses where personal medical information is stored.

All data you provide us is encrypted and stored safely and securely in accordance with security and privacy rules.

Informed Consent Before Participation

Withdraw At Any Time

Strictly Confidential

Your records relating to this study and any other information received will be kept strictly confidential, except as required by the law.

If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.

You will receive a detailed outline of all details of the study, including treatment, risks and procedures, and given the chance to ask questions to study staff, before you decide whether to participate.

Join our new trial email list to be notified of new trials that could be a fit for you.

© 2024 Trialfacts. All Rights Reserved. | (415) 704-1575 USA | (07) 3054 7094 AUS support@trialfacts.com | Privacy Policy