Irvington

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating the efficacy and safety of SPN-812 (viloxazine extended release) in children aged 4 to 5 years who have Attention-Deficit/Hyperactivity Disorder (ADHD). This Phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to compare SPN-812 with a placebo in this preschool-age population to better understand its effects on ADHD symptoms. Participants will be randomly assigned to receive either 100 mg of SPN-812 or a placebo once daily for 6 weeks. Before treatment, there is a screening period lasting up to 4 weeks to determine eligibility. The total study duration is up to 10 weeks, including screening and treatment phases. The study uses a fixed dose and parallel-group design, meaning participants receive one treatment throughout the study. During the study, children will be assessed for changes in ADHD symptoms using a specific rating scale from the start of treatment through Week 6. Researchers will monitor safety and tolerability throughout the trial. Parents or guardians will provide consent and participate in assessments to track symptom changes and treatment effects. The study includes regular evaluations to measure ADHD symptom severity and overall clinical impression.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).

Researchers are evaluating the safety, effectiveness, and tolerability of tenapanor in children aged 12 to less than 18 years who have irritable bowel syndrome with constipation (IBS-C). This Phase 3 study is randomized, double-blind, and placebo-controlled, aiming to compare two doses of tenapanor (25 mg and 50 mg) taken twice daily over 12 weeks. The study includes an initial 2-week screening period to confirm eligibility and collect daily symptom data via an electronic diary (eDiary).