Irvington

Bipolar disorder is a serious, long-lasting mood condition affecting both adults and children. This research focuses on studying the effects and safety of cariprazine, a medication approved for adults, in treating depressive episodes linked to bipolar I disorder in children and adolescents aged 10 to 17. The study aims to better understand how this drug impacts the pediatric population, where treatment options are currently limited. Participants will be randomly assigned to one of two groups one receiving cariprazine at flexible doses adjusted by age and weight, and the other receiving a placebo. The treatment lasts six weeks, with dose adjustments at week 3 depending on response. Following treatment, there is a four-week safety follow-up period. Weekly visits at clinics or hospitals will support monitoring and treatment. During the study, participants will undergo medical assessments, blood tests, questionnaires, and side effect checks to evaluate the drugs impact. Researchers will track changes in mood symptoms using scales like the Childrens Depression Rating Scale and monitor safety through vital signs, lab tests, and movement assessments. The total study participation spans around 10 weeks, including treatment and follow-up.

Researchers are evaluating the efficacy and safety of SPN-812 viloxazine extended release in children aged 4 to 5 years with Attention-DeficitHyperactivity Disorder ADHD. This phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to assess treatment effects and tolerability in this preschool-age group with ADHD symptoms confirmed by specific diagnostic criteria. Participants will be randomly assigned to receive either 100mg of SPN-812 or a placebo once daily for 6 weeks. The study includes a screening period of up to 4 weeks to determine eligibility. The total study duration for each participant is up to 10 weeks, during which the two groups will be compared to evaluate the impact of the medication versus placebo. During the study, children will be assessed using the Attention-DeficitHyperactivity Disorder Rating Scale, 4th Edition, Preschool Version ADHD-RS-IV-P and the Clinical Global Impression scales to measure symptom severity and change. Safety and tolerability will be monitored throughout. Parents or guardians will provide consent, and children will participate in structured activities to help evaluate their symptoms outside the home. Regular study visits will include clinical evaluations and monitoring over the 6-week treatment period.

Researchers are evaluating olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.